2023-02-08| Trials & Approvals

AstraZeneca’s Forxiga Gets EU Nod To Treat Symptomatic Chronic Heart Failure

by Joy Lin
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AstraZeneca has welcomed an approval from the European Commission to expand the indication for Forxiga (dapagliflozin) to treat patients with heart failure across the full range of left ventricular ejection (LVEF), including HF with mildly reduced and preserved ejection fraction (HRmrEF, HFpEF). 

LVEF measures the percentage of blood the left ventricle pumps out of the body with each heartbeat. An LVEF below 40% suggests heart failure. 

Forxiga, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, received its first EU approval in heart failure in 2020 for HRmrEF.

Related Article: GSK’s Jesduvroq Wins FDA Approval for First Oral Drug for Anemia In Chronic Kidney Disease

First Heart Failure Medication to Show Mortality Benefit across the Full Spectrum of LVEF

The latest approval for Forxiga follows the positive opinion of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) last December. It was based on positive data from AstraZeneca’s Deliver Phase 3 trial. The results from a prespecified pooled analysis of Deliver and another Phase 3 trial, Dapa-HF, showed that Forxiga has a mortality benefit across the full ejection fraction range, the first heart failure medication to do so. Specifically, it reduced the rate of cardiovascular death or worsening heart failure by 18% compared to placebo in patients with HRmrEF and HFpEF.

The safety and tolerability of Forxiga in the Deliver trial were also consistent with the established safety profile of the medicine. 

“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,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. 

Forxiga is approved for the treatment of patients with type-2 diabetes, HFrEF, and chronic kidney disease (CKD) in more than 100 countries around the world, including China and Japan. Recently, it received approvals from Great Britain, Japan, and Turkey to extend the HF indication to treat patients across the full spectrum of LVEF. The US FDA is currently reviewing the indication expansion for the drug. 

If greenlighted in the US, Forxiga (known as Farxiga in the US) would compete against Boehringer Ingelheim and Eli Lilly’s popular SGLT2 inhibitor, Jardiance (empagliflozin). 

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