Imfinzi granted breakthrough therapy designation by US FDA for patients with locally-advanced unresectable non-small cell lung cancer

Imfinzi granted breakthrough therapy designation by US FDA for patients with locally-advanced unresectable non-small cell lung cancer

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “For patients who have not progressed following chemoradiation therapy the only current option is active monitoring. Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible.”

The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.

The Breakthrough Therapy Designation for Imfinzi was granted on the basis of interim results from the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. This achievement follows the recent accelerated approval from the US FDA for Imfinzi in previously-treated patients with advanced bladder cancer, and is the fourth Breakthrough Therapy Designation AstraZeneca has received from the FDA for a New Oncology cancer medicine over the past three years, the second for Imfinzi.

Data from the PACIFIC trial have been submitted for presentation at a forthcoming medical meeting.

Imfinzi is also being tested in the adjuvant NSCLC setting in the ADJUVANT Phase III trial. In the Stage IV 1st-line setting for patients with advanced NSCLC, Imfinzi as monotherapy and in combination with tremelimumab, an anti-CTLA4, is being tested in the MYSTIC, NEPTUNE, and PEARL Phase III trials. The POSEIDON trial is evaluating Imfinzi with and without tremelimumab in combination with chemotherapy.

-ENDS-

NOTES TO EDITORS

About PACIFIC

The PACIFIC trial is a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzias sequential treatment in unselected patients with locally-advanced, unresectable (Stage III) NSCLC who have not progressed following platinum-based chemotherapy concurrent with radiation therapy.

The trial is being conducted in 235 centres across 26 countries, including the US, Canada, Europe, South and Central America, Japan, Korea, Taiwan, South Africa and Australia. The primary endpoints of the trial are PFS and OS, and secondary endpoints include landmark PFS and OS, objective response rate and duration of response.

About Imfinzi

Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour’s immune-evading tactics and inducing an immune response.

Imfinzi continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in immuno-oncology. Imfinzi is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular carcinoma (HCC) and haematological malignancies.

About Locally-Advanced (Stage III) NSCLC

Stage III lung cancer is divided into two stages (IIIA and IIIB), which are defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from Stage IV disease, when the cancer has metastasised to other organs.

Stage III lung cancer represents approximately one third of NSCLC incidence and was estimated to affect around 100,000 patients in the G7 countries in 2016. About half of these patients have tumours that are unresectable. The current standard of care is chemotherapy and radiation followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low.

About AstraZeneca in NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths and more than breast, prostate and colorectal cancers combined.

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of NSCLC across all stages of disease and lines of therapy. We aim to address unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa and Tagrisso and on-going FLAURA and ADAURA trials for Tagrisso. Our extensive late-stage immuno-oncology programme focuses on 75-80% of patients with NSCLC without a known genetic mutation. Our portfolio includes Imfinzi, an anti-PD-L1 antibody, which is in development as monotherapy (ADJUVANT, PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in combination with tremelimumab, an anti-CTLA-4 (MYSTIC, NEPTUNE, ARCTIC and POSEIDON trials).

About AstraZeneca’s approach to Immuno-Oncology (IO)

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients.

We are pursuing a comprehensive clinical trial program that includes Imfinzi(anti-PD-L1) monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visitwww.medimmune.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visitwww.astrazeneca.comand follow us on Twitter @AstraZeneca.

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Tagrisso significantly improves progression-free survival in the phase III FLAURA trial for lung cancer

Tagrisso significantly improves progression-free survival in the phase III FLAURA trial for lung cancer

Tagrisso met the primary endpoint, demonstrating a statistically-significant and clinically-meaningful progression-free survival benefit in 1st-line EGFRm non-small cell lung cancer compared to current standard-of-care treatment

AstraZeneca today announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The strong results from the FLAURA trial are very exciting news for patients with EGFR mutation-positive non-small cell lung cancer, providing physicians with a potential new first-line treatment option to improve outcomes in this disease. We will now initiate discussions with global health authorities on the data and regulatory submissions.”

The efficacy, safety and tolerability profiles for Tagrisso, erlotinib and gefitinib were consistent with current knowledge. A full evaluation of the FLAURA data is ongoing. Further results will be presented at a forthcoming medical meeting.

About NSCLCLung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths, more than breast, prostate and colorectal cancers combined. Approximately 10-15% of patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. These patients are particularly sensitive to treatment with currently-available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to EGFR-TKI treatment leading to disease progression. Approximately half of patients develop resistance to approved EGFR-TKIs such as gefitinib and erlotinib due to the resistance mutation, EGFR T790M. Tagrisso targets this secondary mutation that leads to disease progression. There is also a need for agents with improved CNS efficacy since approximately 25% of patients with EGFRm NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.

About Tagrisso
Tagrisso is a third generation, irreversible EGFR tyrosine kinase inhibitor (TKI) designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations, with clinical activity against central nervous system (CNS) metastases. Tagrisso (osimertinib) 40mg and 80mg once-daily oral tablets have been approved in more than 50 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being investigated in the adjuvant and metastatic first-line settings, including in patients with and without CNS metastases, in leptomeningeal metastases, and in combination with other treatments.

About FLAURA

FLAURA assessed the efficacy and safety of Tagrisso 80mg once-daily treatment versus standard-of-care EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously untreated patients with locally advanced or metastatic EGFR mutation-positive NSCLC. The trial was a double-blinded, randomised study, with 556 patients across 30 countries.

The primary endpoint of the trial was PFS, and secondary endpoints included overall survival, objective response rate, duration of response, disease control rate, safety and measures of health-related quality of life (HRQoL).

About AstraZeneca in Lung Cancer

AstraZeneca is using ground-breaking science to develop a wide range of medicines for patients with lung cancer. We are pioneering precision medicines that target molecular mutations in tumour cells, as well as those that aim to boost the power of the immune response against cancer. We are committed to transforming outcomes for patients with lung cancer, whose treatment options are currently limited.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

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Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden – andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

AstraZeneca reports initial results from the ongoing MYSTIC trial in stage IV lung cancer

Imfinzi plus tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy

The MYSTIC trial continues as planned to assess the additional primary endpoints of overall survival for Imfinzi monotherapy and for the Imfinzi plus tremelimumab combination

AstraZeneca and MedImmune, its global biologics research and development arm, today announced progression-free survival (PFS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC).

The combination of Imfinziand tremelimumab did not meet the primary endpoint of improving PFS compared to SoC in patients whose tumours express PD-L1 on 25% or more of their cancer cells (as determined by the VENTANA PD-L1 (SP263) assay).

As a secondary endpoint, although not formally tested, Imfinzi monotherapy would not have met a pre-specified threshold of PFS benefit over SoC in this disease setting.

The trial will continue to assess two additional primary endpoints of overall survival (OS) for Imfinzi monotherapy and OS for the Imfinziplus tremelimumab combination. Final OS data from both primary endpoints are expected during the first half of 2018.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “While the results from the MYSTIC trial for progression free survival in first-line Stage IV non-small cell lung cancer compared with standard of care are disappointing, the trial was designed to assess overall survival and we look forward to evaluating the remaining primary endpoints of overall survival for both mono- and combination therapy.”

AstraZeneca recently received accelerated approval from the US FDA for Imfinzi in previously-treated patients with locally advanced or metastatic urothelial carcinoma (mUC).

About MYSTICThe MYSTIC trial is a randomised, open-label, multi-centre, global Phase III trial of Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus SoC in treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally-advanced or metastatic (Stage IV) 1st-line NSCLC. Lung cancer is an unapproved use of Imfinzi.

The trial is being conducted in 167 centres across 17 countries, including the US, Canada, Europe, parts of Asia including Japan, Korea, Thailand, Taiwan and Vietnam, and in Russia and Australia. Primary endpoints include PFS and OS.

About Imfinzi

Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour’s immune-evading tactics and inducing an immune response.

Imfinzi continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in immuno-oncology. Imfinzi is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in mUC and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase III trials in mUC, NSCLC, SCLC and HNSCC and in Phase I/II trials in hepatocellular carcinoma (HCC) and haematological malignancies.

About Tremelimumab

Tremelimumab is an investigational human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being investigated in an extensive clinical trial programme in combination with Imfinzi, in NSCLC, mUC, HNSCC, HCC and blood cancers.

About AstraZeneca in NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths and more than breast, prostate and colorectal cancers combined.

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of NSCLC across all stages of disease and lines of therapy. We aim to address unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa and Tagrisso and ongoing FLAURA and ADAURA trials. Our extensive late-stage immuno-oncology programme focuses on 75-80% of patients with NSCLC without a known genetic mutation. Our portfolio includes Imfinzi (durvalumab), an anti-PDL1 antibody, which is in development as monotherapy (ADJUVANT, PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in combination with tremelimumab, an anti-CTLA-4 (MYSTIC, NEPTUNE and POSEIDON trials).

About AstraZeneca’s approach to Immuno-Oncology

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients.

We are pursuing a comprehensive clinical trial programme that includes Imfinzi (anti-PDL1) monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, MD, one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

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Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden – andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Faslodex receives EU approval as first-line therapy for advanced breast cancer

Faslodex receives EU approval as first-line therapy for advanced breast cancer

Faslodex reduced risk of disease progression by 20%  vs anastrozole, the current standard treatment option

Potential new first-line standard of care for postmenopausal women with oestrogen-receptor positive locally-advanced or metastatic disease

AstraZeneca today announced that the European Commission (EC) has approved Faslodex (fulvestrant) for the treatment of oestrogen-receptor positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

The EU approval is based on pivotal data from the Phase III FALCON trial, which demonstrated the superiority of Faslodex 500mg over anastrozole 1mg as a first-line treatment for postmenopausal women with locally-advanced or HR+ metastatic breast cancer who had not received prior hormone-based therapy.

In the FALCON trial, median progression-free survival (PFS) was significantly longer with Faslodex than with the aromatase inhibitor, anastrozole – 16.6 months versus 13.8 months (HR: 0.797; 95% CI: 0.637-0.999; p=0.0486). Aromatase inhibitors such as anastrozole are the current standard of care for the first-line treatment for postmenopausal women with HR+ advanced breast cancer.

Jamie Freedman, Executive Vice-President and Head of AstraZeneca’s Oncology Business Unit, said: “This new EU approval shows the scientific strength of Faslodex with more than 15 years of clinical experience. Postmenopausal women with hormone receptor-positive advanced breast cancer can now benefit from Faslodex at an earlier stage in their disease. We continue to explore the full potential of this important medicine as monotherapy and in combination with other medicines.”

Matthew Ellis, MD, PhD, study investigator, and director of the Lester and Sue Smith Breast Center in the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine in Houston, said: “A 20% reduction in disease progression or death observed with fulvestrant compared to the current standard therapy is an advance in the management of postmenopausal women diagnosed with previously untreated hormone receptor-positive advanced breast cancer. The study provides evidence that the earlier use of fulvestrant in these patients will prolong the time before the disease progresses, which requires a change to a second line drug.”

The safety and tolerability profiles for Faslodex and anastrozole reported in the FALCON trial were in line with current experience. The most-commonly reported adverse events (AEs) in the Faslodex and anastrozole arms were arthralgia (16.7% vs. 10.3%), hot flush (11.4% vs. 10.3%) and nausea (10.5% vs. 10.3%).

Faslodex is the only hormonal medicine for advanced breast cancer that slows tumour growth by binding to and degrading the oestrogen receptor – a key driver of breast cancer progression in some women. It is widely approved for the treatment of HR+ advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen medicine.

Faslodex was first approved in 2002 and is currently being tested in combination with over 19 different medicines for the treatment of women with advanced HR+ breast cancer.

About FALCON

The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy-Naïve advanced breast cancer) trial is a Phase III, randomised, double-blind, multicentre trial comparing the antitumour effects and tolerability profile of a 500mg dose of Faslodex plus placebo with a 1mg dose of anastrozole plus placebo, in postmenopausal women with HR+, locally-advanced or metastatic breast cancer who have not been treated previously with any hormonal medicine.

The FALCON trial was designed on the basis of positive results from the Phase II FIRST trial, which demonstrated a median overall survival nearly six months longer with Faslodex compared to anastrozole.

About Advanced Breast Cancer

Advanced/metastatic breast cancer refers to Stage III and IV breast cancer. Stage III disease may also be referred to as locally-advanced breast cancer, while metastatic disease is the most-advanced stage of breast cancer (Stage IV), and occurs when cancer cells have spread beyond the initial tumour site to other organs of the body outside the breast. Since there is no cure for the disease, the goal of current treatment is to delay disease worsening or death.

About Faslodex

Faslodex (fulvestrant) is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy.

In the US, Faslodex is also approved, in combination with palbociclib, for the treatment of women with HR+, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine. Faslodex represents a hormonal treatment approach that helps to slow tumour growth by blocking and degrading the oestrogen receptor – a key driver of disease progression.

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody-Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
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Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks

Finance, Fixed Income, M&A

+44 7881 615 764

Henry Wheeler

Oncology

+44 203 749 5797

Mitchell Chan

Oncology

+1 240 477 3771

Lindsey Trickett

Cardiovascular & Metabolic Diseases

+1 240 543 7970

Nick Stone

Respiratory

+44 203 749 5716

Christer Gruvris

Autoimmunity, Neuroscience & Infection +44 203 749 5711
US toll free +1 866 381 7277

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden – andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Xarelto i kombination med enkel trombocythämmande behandling får s.k. ”positive opinion” från Committee for Medicinal Products for Human Use (CHMP)

Xarelto i kombination med enkel trombocythämmande behandling får s.k. ”positive opinion” från Committee for Medicinal Products for Human Use (CHMP)

Data från Fas IIIb-studien PIONEER AF-PCI visar signifikant minskad blödningsrisk med Xarelto jämfört med Vitamin k-antagonist hos patienter med icke-valvulärt förmaksflimmer som också får trombocythämmande behandling efter genomgången PCI med stent. PIONEER AF-PCI är den första och hittills enda randomiserade kliniska studien på ett NOAK i denna patientgrupp.

Berlin, 21 juli 2017 – Bayer kan idag meddela att CHMP vid Europiska Läkemedelsmyndigheten (EMA) har gett ett positivt utlåtande till uppdatering av produktinformationen för 15 mg daglig endos av Factor Xa-hämmaren Xarelto (Rivaroxaban) i kombination med en P2Y12-hämmare för behandling av patienter med icke-valvulärt förmaksflimmer, som behöver oral antikoagulantia och genomgår perkutan koronar intervention (PCI) med stent. Slutgiltigt beslut från Europeiska kommissionen väntas komma under tredje kvartalet i år.

– CHMPs rekommendation är ett viktigt steg för en förbättrad behandling av dessa högriskpatienter med förmaksflimmer, som inte bara behöver strokeförebyggande antikoagulationsbehandling, utan också på grund av den ökade risken för trombos associerad med PCI och inläggning av stent i blodkärlet. Den nuvarande behandlingen har medfört en förhöjd risk för blödningar, även i hjärnan. Mot den bakgrunden är det extra uppmuntrande att i jämförelse med den Vitamin k-antagonist baserade behandlingen som prövades i PIONEER AF-PCI, så minskade Rivaroxaban 15 mg dagligen i kombination med enkel trombocythämmande behandling signifikant risken för kliniskt signifikant blödning i patientgruppen med 41 procent, säger docent Peter Båvenholm på Bayer Sverige.

Förmaksflimmer är det vanligaste hjärthälsoproblemet i världen och uppskattningsvis 33,5 miljoner människor är drabbade[i]. 20 – 40 procent av dem har också en samtidig kranskärlssjukdom[ii],[iii]. Mellan 5 och 15 procent av patienterna med förmaksflimmer kommer att behöva genomgå PCI med stentinläggning någon gång i livet[iv]. Dessa patienter har en högre risk att få blodproppar vilket kan leda till både stroke och hjärtinfarkt.

Det positiva CHMP-utlåtandet bygger på data från fas IIIb-studien PIONEER AF-PCI, som publicerades i The New England Journal of Medicine i december 2016. Där framkom att rivaroxaban 15 mg en gång dagligen i kombination med enkel trombocythämmande behandling signifikant minskade antalet fall av kliniskt signifikanta blödningar med 41 procent (relativ riskminskning; motsvarande 9.9 procent absolut riskreduktion) i jämförelse med den Vitamin k-antagonist baserade behandlingen plus upp till 12 månaders randomiserad dubbel trombocythämmande behandling för patienter med icke-valvulärt förmaksflimmer, som behöver oral antikoagulantia och genomgår PCI med stentinläggning. Rivaroxabanbehandlingen hade liknande resultat för den explorativa sluthändelsen, kardiovaskulär död, hjärtinfarkt, stroke och stenttrombos jämfört med strategin med vitamin K-antagonist. Studien var primärt utformad för att bedöma säkerhet, vad gäller effekt är denna inte statistiskt säkerställd på grund av studiens begränsade omfattning.

PIONEER AF-PCI är den första randomiserade studien på ett NOAK i den här patientgruppen. Den kompletterar det omfattande studieprogrammet på rivaroxaban som innehåller fler än 275,000 patienter i både kliniska studier och erfarenheter från klinisk rutinsjukvård.

För mer information om Xarelto: www.xarelto.se

För mer information om blodpropp: www.thrombosisadviser.com

För mer information om förebyggande av blodpropp och stroke: www.thrombocoach.com

[i] Chugh SS, Havmoeller R, Narayanan K, et al. Arrhythmia/Electrophysiology. Circulation. 2014: 129-837- 847

[ii]The AFFIRM Investigators. Baseline characteristics of patients with atrial fibrillation: the AFFIRM Study. American Heart Journal 2002;143:991–1001

[iii]Carpodanno D, Angiolillo DJ. Management of Antiplatelet and Anticoagulant Therapy in Patients With Atrial Fibrillation in the Setting of Acute Coronary Syndromes or Percutaneous Coronary Interventions. Circulation: Cardiovascular Interventions 2014;7:113–124

[iv] Kirchhof P, Benussi S, Kotecha D, et al. Eur Heart J 2016:doi:10.1093/eurheartj/ehw210

Om Bayer
Bayer är en global koncern med kärnkompetens inom life science-områdena hälsa och jordbruk. Våra produkter och tjänster syftar till att förbättra livskvaliteten hos såväl människor som djur. Bayer har som målsättning att skapa värde genom innovation, tillväxt och hög intjäningsförmåga. Bayer har förbundit sig att följa principerna för hållbar utveckling och att agera som ett socialt och etiskt ansvarstagande företag. 2016 hade Bayer cirka 115 000 anställdaoch en omsättning på 46,8 miljarder euro. Kapitalkostnaderna uppgick till 2,6 miljarder euro och investeringarna i forskning och utveckling till 4,7 miljarder euro. Dessa siffror inkluderar den verksamhet inom högteknologiska material som börsintroducerades den 6 oktober 2015 som ett självständigt bolag med namnet Covestro. För mer information, besök www.bayer.se.

KYNTHEUM APPROVED IN THE EU FOR THE TREATMENT OF ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS

KYNTHEUM APPROVED IN THE EU FOR THE TREATMENT OF ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that its partner LEO Pharma has been granted full marketing authorisation in all 28 EU member countries plus Iceland, Liechtenstein and Norway for Kyntheum (brodalumab), a new biologic medicine developed for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.1 Kyntheum is the first and only biologic that selectively targets the IL-17 receptor subunit A.2,3

By binding to this specific receptor subunit on the cells of the skin, rather than targeting free inflammatory mediators, Kyntheum blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in plaque formation.2,4,5

Psoriasis is a common, chronic, immune-mediated inflammatory skin disease affecting an estimated 125 million people worldwide, including nearly 14 million Europeans.6,7,8 It primarily affects the skin, but carries with it a substantial social and psychological burden, even when a relatively small proportion of body surface is affected.4

The AMAGINE clinical trial programme (AMAGINE 1-3) involved 4,373 patients with moderate-to-severe psoriasis, the largest study population in the development programme of any new biologic medicine for psoriasis to date.9-17

In July 2016, AstraZeneca announced an agreement granting LEO Pharma, a specialist in dermatology, exclusive rights to develop and commercialise Kyntheumin Europe. Outside of Europe, Valeant Pharmaceuticals has global commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co., Ltd. Brodalumab is currently approved in the US (under the brand name Siliq) and in Japan for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

– ENDS –

NOTES TO EDITORS

About Kyntheum

Kyntheum (brodalumab) is the only fully-human monoclonal antibody that selectively targets the IL-17 receptor subunit A.2,3 By binding to the receptor with high affinity, Kyntheumeffectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis.3,7

The psoriasisclinical trials programme for Kyntheum consisted of three clinical trials; AMAGINE-1 (661 patients), AMAGINE-2 (1831 patients) and AMAGINE-3 (1881 patients).11,12Results showed Kyntheum 210mg offered many patients complete skin clearance (Psoriasis Area Severity Index [PASI] 100) at 12 weeks compared to patients treated with ustekinumab [AMAGINE-2: 44% (n=272) versus 22% (n=65), p<0.001; AMAGINE-3: 37% (n=229) versus 19% (n=58), p<0.001].11

In AMAGINE-1, 83% of patients on Kyntheum210mg achieved PASI 75* compared to 3% of patients treated with placebo at 12 weeks [83.3% (n=185) versus 2.7% (n=6), p<0.001] and 76% of patients achieved sPGA** success versus 1% of patients treated with placebo [75.7% (n=168) versus 1.4% (n=3), p<0.001].12

Data from the three, large, randomised, controlled AMAGINE clinical trials found Kyntheum to be well tolerated, with an acceptable safety profile. The most common adverse events were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx), headache, and upper respiratory tract infection.12 Although cases of suicidal ideation and behaviour were reported, no causal association between treatment with Kyntheum and increased risk of suicidal ideation and behaviour has been established. Kyntheum’s launch in Europe will be supported by post-marketing pharmacovigilance activities to capture and follow up on any reports of safety events.

* PASI 75 is defined as ≥ 75% improvement in Psoriasis Area Severity Index score

**sPGA success is defined as patients who achieved a static Physician’s Global Assessment 0 or 1

About psoriasis

Psoriasis is a common, chronic, immune-mediated, inflammatory skin disease.4 The most-frequently reported symptoms include thickening and scaling of the skin, itching and erythema (superficial reddening of the skin, usually in patches).4 An estimated 125 million people worldwide live with psoriasis, including nearly 14 million Europeans.5,6

About LEO Pharma

LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. LEO Pharma offers a comprehensive range of integrated care solutions for control and relief of psoriasis. By expanding its portfolio into biologics, through the approval of Kyntheum, the company is set to become the world’s leading dermatology company.

Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding
Matt Kent
UK/Global
UK/Global
+44 203 749 5821
+44 203 749 5906
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology +1 240 477 3771
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Nick Stone Respiratory +44 203 749 5716
Christer Gruvris Autoimmunity, Neuroscience & Infection +44 203 749 5711
US toll free +1 866 381 7277

References

1 European Medicines Agency, 19 July 2017: http://ec.europa.eu/health/documents/community-register/html/h1155.htm

2 Campa M, et al. Dermatol Ther. 2016;6:1–12

3 Coimbra S, et al. Core Evidence. 2014;9:89-97

4 Beringer A, et al. Trends Mol Med. 2016; 22: 230-41

5 Russell CB, et al. J Immunol. 2014; 192: 3828-36

6 World Health Organization (WHO). Global Report on Psoriasis. Available from: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf (Accessed July 2017)

7 The International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/ (Accessed July 2017)

8 Ortonne J, et al. Eur J Dermatol. 2004;14:41–45

9 Lebwohl M, et al. N Engl J Med 2015;373:1318-28

10 Papp K, et al. Br J Dermatol. 2016;175:273–286

11 European Medicines Agency. EPAR summary for the public: Cosentyx. 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Summary_for_the_public/human/003729/WC500183132.pdf (Accessed July 2017)

12 Taltz®. Summary of Product Characteristics 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/003943/WC500205804.pdf (Accessed July 2017)

13 Stelara®. Summary of Product Characteristics 2009. Available from: https://www.medicines.org.uk/emc/medicine/32569 (Accessed July 2017)

14 Enbrel®. Summary of Product Characteristics 2000. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/000262/WC500027361.pdf (Accessed July 2017)

15 Humira®. Summary of Product Charateristics 2003. Available from: https://www.medicines.org.uk/emc/medicine/31860 (Accessed July 2017)

16 Remicade®. Summary of Product Characteristics 1999. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/000240/WC500050888.pdf (Accessed July 2017)

17 National Institute for Health and Care Excellence (NICE) Psoriasis: assessment and management guidelines. Available at: https://www.nice.org.uk/guidance/cg153/chapter/1-Guidance#systemic-therapy (Accessed July 2017)

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden – andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Restsituation för Trisenox har uppstått

Läkemedelsverket meddelade tidigare (2017-07-14) att en restsituation för läkemedlet Trisenox (arseniktrioxid) skulle uppstå i mitten/slutet av augusti, men restsituation har redan uppstått i Sverige och lagernivåerna i andra EU-länder minskar successivt. Nästa leverans av Trisenox beräknas enligt företaget komma till Sverige i december 2017.

Trisenox koncentrat till infusionsvätska, lösning 1 mg/ml, innehåller arseniktrioxid. Läkemedlet används till vuxna patienter med nydiagnosticerad akut promyelocytleukemi (APL) med låg till intermediär risk, samt när sjukdomen återkommit eller inte har blivit bättre efter andra behandlingar.

Alternativ
Det finns möjlighet att ansöka om licens för läkemedel godkänt i annat land för att täcka behov av läkemedel under restsituationen. Förskrivare rekommenderas att vända sig till ett apotek för att få information om tillgänglighet för sådana produkter. Länk till Läkemedelsverkets information om licens finns under relaterad information till höger.

Kontakt 
Licensgruppen
Mån-fre 9–11och 14.30–16
Tel: 018-17 46 60
E-post:licensgruppen@mpa.se

Läkemedelsverkets uppgift är att se till att den enskilde patienten, hälso- och sjukvården samt djursjukvården får tillgång till säkra och effektiva läkemedel av god kvalitet och att dessa används ändamålsenligt och kostnadseffektivt. Myndigheten ansvarar också för tillsyn av medicintekniska produkter, tatueringsfärger samt kosmetiska och hygieniska produkter. Läs mer om oss på www.lakemedelsverket.se.

Flaggningsmeddelande

Flaggningsmeddelande

Idogen AB (”Idogen”) meddelar att bolagets största aktieägare, HCN Group AB, i samband med den genomförda företrädesemissionen har tecknat nya aktier i Idogen för motsvarande 6,3 MSEK, och därmed ökat sitt aktieinnehav i Idogen till 10,84 procent av rösterna och aktiekapitalet.

Idogens enskilt största aktieägare, HCN Group AB, har tecknat ytterligare aktier i bolaget i samband med företrädesemissionen och flaggar härmed upp sitt ägande i Bolaget. Före företrädesemissionen ägde HCN Group AB 1 204 208 aktier, motsvarande 9,85 procent av rösterna och aktiekapitalet i Idogen, och efter företrädesemissionens genomförande äger HCN Group AB 2 252 934 aktier, motsvarande 10,84 procent av rösterna och aktiekapitalet i Idogen AB efter företrädesemissionens genomförande.

För ytterligare information, vänligen kontakta:

Lars Hedbys, VD

Tel: 046-275 63 30

E-post: lars.hedbys@idogen.com

Idogen utvecklar tolerogena vacciner som programmerar om immunförsvaret. Benämningen ”tolerogen” kommer av att immunförsvaret efter behandling med Idogens terapi selektivt tolererar ett utvalt sjukdomsframkallande antigen. Det innebär en ny behandlingsmetod för svåra sjukdomar med stort medicinskt behov som idag saknar bot ‒ såsom autoimmuna sjukdomar, organavstötning efter transplantation och patienter som har utvecklat antikroppar mot behandling med biologiska läkemedel. Behandlingen bygger på att celler från patientens blod programmeras till dendritiska celler med kapacitet att specifikt motverka den egna kroppens skadliga immunreaktion, utan att påverka immunsystemets funktion i övrigt. Idogens första produkt riktar sig till patienter med svår blödarsjuka (hemofili A) som drabbats av hämmande antikroppar mot sin livsviktiga behandling med koagulationsfaktor VIII. Bolagets nästa terapiområde är ett tolerogent vaccin för att förhindra organavstötning vid transplantation, primärt njurtransplantation. Idogens tolerogena vaccin förväntas minska behovet av immunhämmande läkemedel och förbättra transplantatöverlevnaden, samt därmed samtidigt minska risken för cancer och infektioner. Idogen grundades år 2008 från en immunologisk upptäckt vid Lunds Universitet. För mer information, besök www.idogen.com.

Att sluta snusa har ingen effekt på konditionen

Att sluta snusa har ingen effekt på konditionen

Syftet med studien var att undersöka effekten av kondition och hälsa efter det att deltagare slutat att snusa. Totalt deltog 42 personer i åldern 30-40 år som skulle ha snusat i minst två år och som tränade cirka tre gånger i veckan. Resultaten på den grupp som slutade snusa visade ingen skillnad på prestationen och konditionen. Däremot ökade deltagarna i vikt och fick lägre blodtryck.
– Det finns alltså ingen anledning att sluta snusa för att få bättre kondition, men kroppen kan ändå påverkas genom andra effekter på hälsan, säger Frida Björkman, doktorand vid GIH.

Två grupper bildades – en kontrollgrupp som fortsatte att snusa och en som slutade att snusa. Efter sex veckor genomfördes testerna då effekterna av snusningen har gått ur kroppen. Deltagarna lämnade blodprov och det togs blodtryck när kroppen var i vila, under och efter ett timslångt träningspass och efter ett maxpass. Deltagarna fick instruktioner att hålla exakt samma diet ett dygn innan för- och eftertesterna och ombads att avstå från ansträngande träning, alkohol, kaffe och te.

De flesta deltagare tränade som vanligt under själva studien, men många deltagare i gruppen som slutade snusa rapporterade att de hade börjat äta olika typer av snacks, som till exempel choklad och andra feta produkter för att dämpa nikotinbehovet. De som deltog hade innan studien ett genomsnittligt BMI på 24,3 och efter studien var den 24,8. Personer med normalvikt har ett BMI på mellan 19 och 25. Personer med ett BMI på mellan 26 och 30 anses vara överviktiga.
– Så gott som alla deltagare gick upp ungefär 1,5 kilo i vikt, men de kan gå tillbaka till sin ursprungsvikt när abstinensbesvären inte längre behöver lindras med godis, säger Frida Björkman.

Denna studie är den första som har undersökt effekter av snusavbrott efter flera års användning. Förutom att vikten ökade, blodtrycket sjönk, kolesterol ökade så var C-reaktivt protein och fria fettsyror lika i båda grupperna. Sammanfattningsvis verkar utövandet av uthållighet inte ha drabbats av långvarigt snusande, men effekterna på riskerna för den kardiovaskulära ohälsan är motsägelsefulla.

Snus innehåller cirka åtta milligram nikotin per gram snus och flera tusen andra ingredienser. Snus har en cancerframkallande effekt på bukspottkörteln och kan eventuellt även påverka andra organ. Det finns även studier som pekar på att snusande ökar risken för kardiovaskulär sjukdom.

Artikeln är publicerad i den vetenskapliga tidskriften PLOS ONE som har open access.

För mer information kontakta:
Frida Björkman, doktorand GIH, tel: 072- 262 70 67, e-post: frida.bjorkman@gih.se
Björn Ekblom, professor emeritus GIH, tel: 070-726 72 82, e-post: bjorn.ekblom@gih.se
Mikael Mattsson, medicine doktor GIH, tel: 073-536 73 62, e-post: mikael.mattson@gih.se
Louise Ekström, kommunikationsansvarig GIH, tel: 070-202 85 86, e-post: louise.ekstrom@gih.se

Gymnastik- och idrottshögskolan, GIH, är världens äldsta idrottshögskola. Lärosätet ligger vid Stockholms Stadion och är Sveriges främsta kunskapscentrum för idrott, fysisk aktivitet och hälsa. Här utbildas lärare i idrott och hälsa, tränare, hälsopedagoger, sport managers, idrottsvetare och forskare. GIH bedriver idrottsvetenskaplig forskning, ofta i nära samarbete med andra lärosäten och intressenter i samhället, på både nationell och internationell nivå. GIH har idag 140 medarbetare och cirka 1 000 studenter.