AZ’s Forxiga wins EU approval for heart failure

AstraZeneca’s Forxiga (dapagliflozin) has been approved in the EU for the treatment of symptomatic heart failure with reduced ejection fraction (HFrEF).

The SGLT2 inhibitor has been approved in this indication for the treatment of adult patients with and without diabetes, widening its potential reach in the heart failure market.

The European Commission approval is based on results from the DAPA-HF phase III trial, which demonstrated that Forxiga, added to standard of care, reduced the risk of the composite outcome versus placebo by 26%.

In addition, both components of the primary composite endpoint contributed benefit to the overall effect.

The primary composite endpoint was time to the first occurrence of a worsening heart failure event or cardiovascular death.

Forxiga is already approved, under the brand name Farxiga, in the US for the treatment of patients with HFrEF and is currently under review in Japan and several other countries globally.

“With this approval of Forxiga, we can redefine the standard of care for millions of people in the EU living with heart failure,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.

“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,” he added.

Heart failure affects around 15 million people in the EU, with at least half of those having a reduced ejection fraction. This occurs when the left ventricle muscle cannot contract adequately and therefore expels less oxygen-rich blood into the body.