Forxiga approved in EU for chronic heart failure

Forxiga (dapagliflozin) has been approved in the European Union for heart failure (HF) with reduced ejection fraction (HFrEF) across the full spectrum of left ventricular ejection fraction (LVEF).

AstraZeneca’s Forxiga is the first and only heart failure therapy with proven mortality benefit across the full ejection fraction range. The first-in-class, oral, once-daily SGLT2 inhibitor has shown efficacy in preventing and delaying cardiorenal disease, while also protecting the organs, research has shown.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) in December 2022. It was based on the positive results from the DELIVER Phase III trial, comparing Forxiga with placebo. This was the largest clinical trial to date in HF patients with LVEF above 40 percent, with 6,263 randomised patients.

Forxiga (dapagliflozin)

Forxiga is approved for type-2 diabetes (T2D), HFrEF and chronic kidney disease (CKD) in more than 100 countries around the world including the US, the EU, China and Japan. It has most recently received regulatory approvals in Great Britain, Japan and Turkey to extend the HF indication to include patients across the full spectrum of LVEF. The HF indication extension application is currently under review in the US and other countries.

“This broader indication for Forxiga for the treatment of symptomatic chronic heart failure across the full ejection fraction range will help more patients to benefit from this well-tolerated and guideline-directed treatment,” commented Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca.

Heart failure

HF affects nearly 64 million people globally, according to a study published in the Lancet in 2017. Research shows approximately half of all HF patients have mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), with few therapeutic options available. Approximately half of HF patients die within five years of diagnosis, according to a report by the American Heart Association.