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AstraZeneca: FDA grants Fast Track designation for Farxiga in heart failure

08:06 AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The FDAs Fast Track programme is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: Heart failure affects approximately 64 million people worldwide, and about half will die within five years of diagnosis. This Fast Track designation for Farxiga brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore Farxiga as a potential new treatment option for heart failure patients. The Fast Track designation is based on two Phase III trials, DAPA-HF and DELIVER, which investigated the role of Farxiga in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively. Farxiga is currently approved as a monotherapy and as part of combination therapy to improve glycaemic control in adults with type-2 diabetes (T2D). In August 2019 (https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/fda-grants-fast-track-designation-for-farxiga-in-chronic-kidney-disease-27082019.html) the FDA granted Fast Track designation for the development of Farxiga to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease. About heart failure Heart failure (HF) is a life-threatening disease in which the heart cannot pump enough blood around the body.[1] It affects approximately 64 million people worldwide (at least half of which have a reduced ejection fraction) and is a chronic and degenerative disease where half of patients will die within five years of diagnosis.[2,3,4] HF remains as malignant as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancers).[5] It is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden.[6] About Farxiga Farxiga is a first-in-class, oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2D. Farxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years experience. About the DapaCare Clinical Programme AstraZeneca is taking a holistic, patient-centric approach to disease management by addressing the underlying morbidity, mortality and organ damage associated with CV, metabolic and renal diseases. Due to the interconnectivity of these diseases, AstraZeneca has developed the DapaCare clinical programme to explore the CV and renal profile of Farxiga in people with and without T2D. The clinical programme will enrol nearly 30,000 patients in randomised clinical trials and is supported by a multinational real-world evidence study. DapaCare will generate data across a spectrum of people with established CV disease, CV risk factors and varying stages of renal disease, both with and without T2D, providing healthcare providers with evidence needed to improve patient outcomes. Farxiga is also being developed for patients with HF in the DELIVER (HFpEF) and DETERMINE (HFrEF and HFpEF) trials, in addition to chronic kidney disease in the DAPA-CKD trial. DapaCare underscores our commitment to following the science by pursuing a holistic patient approach to address the multiple risk factors associated with CV, renal and metabolic diseases. About AstraZeneca in heart failure AstraZeneca is committed to advancing science and clinical outcomes with Farxiga in the treatment of people with HF. The companys extensive clinical programme includes several global Phase III trials (DAPA-HF, DELIVER and DETERMINE) focusing on distinct and clinically important areas of HF research in order to provide comprehensive clinical evidence around the disease and address areas of high unmet need in HF. AstraZeneca is also investing its efforts in compelling new science through early-stage research of several potential medicines to address HF. About AstraZeneca in CVRM Cardiovascular, Renal & Metabolism (CVRM) together forms one of AstraZenecas three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Companys ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients 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 therapy areas - Oncology, Cardiovascular, Renal and Metabolism (CVRM), and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca (https://twitter.com/AstraZeneca). Media Relations Gonzalo Via +44 203 749 5916 Rob Skelding Oncology +44 203 749 5821 Rebecca Einhorn Oncology +1 301 518 4122 Matt Kent BioPharmaceuticals +44 203 749 5906 Jennifer Hursit Other +44 203 749 5762 Christina Sweden +46 8 552 53 106 Malmberg Hägerstrand Michele Meixell US +1 302 885 2677 Investor Relations Thomas Kudsk +44 203 749 5712 Larsen Henry Wheeler Oncology +44 203 749 5797 Christer BioPharmaceuticals (CV, metabolism) +44 203 749 5711 Gruvris Nick Stone BioPharmaceuticals (respiratory, renal) +44 203 749 5716 Josie Afolabi Other medicines +44 203 749 5631 Craig Marks Finance, fixed income +44 7881 615 764 Jennifer Corporate access, retail investors +44 203 749 5824 Kretzmann US toll-free +1 866 381 72 77 References 1. Mayo Clinic. Heart failure; 2017 [cited 2019 Aug 14]. Available from URL: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142. 2. Vos T et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. The Lancet 2017; 390(10100):1211-59. 3. Travessa AMR, Menezes Falco LF de. Treatment of Heart Failure With Reduced Ejection Fraction-Recent Developments. Am J Ther. 2016;23(2):e531-49. doi:10.1097/MJT.0000000000000406. 4. Mozaffarian D et al. Circulation. 2016 Jan 26;133(4):e38-360 and the CDC: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm 5. Mamas, M. A., Sperrin, M., Watson, M. C., Coutts, A., Wilde, K., Burton, C., ... Myint, P. K. (2017). Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. European Journal of Heart Failure, 19(9), 1095-1104. https://doi.org/10.1002/ejhf.822 6. Azad, N., & Lemay, G. (2014). Management of chronic heart failure in the older population. Journal of Geriatric Cardiology: JGC, 11(4), 329-37. Christina Malmberg HägerstrandPresschef AstraZeneca AB och Norden Baltikum+ 46 8 552 53 106 christina.malmberghagerstrand@astrazeneca.com ----------------------------------------------------------- https://news.cision.com/se/astrazeneca/r/fda-grants-fast-track-designation-for-farxiga-in-heart-failure,c2904696 © Cision

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