AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation 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 in which the heart cannot pump enough blood around the body,1 affecting 15 million people in the EU, at least half of which have a reduced ejection fraction.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the landmark DAPA-HF Phase III trial, published in The New England Journal of Medicine.

Forxiga is the first SGLT2 inhibitor to have shown a statistically significant reduction in the risk of cardiovascular (CV) death or worsening of HF events (including hospitalization for HF, hHF) versus placebo where both components of the primary composite endpoint contributed benefit to the overall effect. In the DAPA-HF Phase III trial, the safety profile of Forxiga was consistent with the well-established safety profile of the medicine.

John McMurray, MD, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, said: “I am delighted that we may soon have a new treatment that is effective, safe and simple to use for patients with heart failure with reduced ejection fraction. Dapagliflozin is a major and welcome breakthrough with the potential to improve not only the quality but also importantly, the length of life for millions of people suffering from this terrible disease in Europe and throughout the world.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The unmet need for novel medicines in heart failure remains high, with more than half of patients expected to die within five years of diagnosis. Novel treatment options reducing cardiovascular death and hospitalization, in addition to improving symptoms, are urgently needed. With the positive opinion for Forxiga, we are one step closer to transforming the standard of care for millions of people in the EU living with heart failure.”

The CHMP recommendation states Forxiga is indicated in adults for the treatment of symptomatic chronic HFrEF.