The sodium–glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin has been recommended for an extension of its marketing authorisation in the EU to include treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF), in adults with and without type 2 diabetes. If approved, it would become the first SGLT2 inhibitor to receive this licence in the EU.
The recommendation, from the Committee for Medicinal Products for Human Use (CHMP), was based on results of the Phase 3 DAPA-HF study, which showed that dapagliflozin, in addition to the standard of care, reduced the risk of the composite outcome of cardiovascular death or worsening of HF by 26% compared with placebo, an absolute risk reduction of 4.9%.
John McMurray, the lead study author of DAPA-HF, 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.”