Forxiga approved in the EU for heart failure.- AstraZeneca

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). 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, which occurs when the left ventricle muscle is not able to contract adequately and therefore expels less oxygen-rich blood into the body. The approval by the European Commission is based on positive results from the landmark DAPA-HF Phase III trial, published in The New England Journal of Medicine. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.