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Forxiga approved in the EU for heart failure
Forxiga approved in the EU for heart failure.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 3128E\n AstraZeneca PLC\n 05 November 2020\n \n \n \n 5 November 2020 07:05 GMT\n \n \n \n Forxiga\n \n \n approved in the EU for heart failure\n \n \n \n \n \n \n Forxiga is the first SGLT2 inhibitor approved in the EU for heart failure \n \n \n with reduced ejection fraction in adult patients with and without type-2 diabetes\n \n \n \n \n \n AstraZeneca's Forxiga (dapagliflozin) has been approved in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D).\n \n \n \n \n \n Heart failure (HF) is a life-threatening chronic disease that prevents the heart from pumping sufficient levels of blood around the body. It affects 15 million people in the EU, at least half of whom have a reduced ejection fraction,1-3 which occurs when the left ventricle muscle is not able to contract adequately and therefore expels less oxygen-rich blood into the body.4-6\n \n \n \n \n \n The approval by the European Commission is based on positive results from the landmark DAPA-HF Phase III trial, published in \n \n The New England Journal of Medicine\n \n .7 It follows the \n \n recommendation for approval\n \n by the Committee for Medicinal Products for Human Use of the European Medicines Agency.\n \n \n \n \n \n John McMurray\n , MD, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, said: \"Today's approval provides physicians with a completely novel treatment for heart failure with reduced ejection fraction, not only improving symptoms and reducing hospital admissions, but also increasing survival in this life-threatening condition.\"\n \n \n \n \n \n Mene Pangalos\n , Executive Vice President, BioPharmaceuticals R&D, said: \"With this approval of Forxiga, we can redefine the standard of care for millions of people in the EU living with heart failure. We are another step closer to achieving our ambition of preventing or treating heart failure by providing a treatment that can significantly reduce cardiovascular death and hospitalisation.\"\n \n \n \n \n \n Forxiga is the first sodium-glucose co-transporter-2 (SGLT2) inhibitor to have shown a statistically significant reduction in the risk of ...