EU approves AstraZeneca's Forxiga for broader heart failure treatment
The European Commission has approved AstraZeneca's Forxiga (dapagliflozin) for the treatment of symptomatic chronic heart failure across the full range of left ventricular ejection fraction. This expands the drug's previous indication.
AstraZeneca announced that the European Commission has approved Forxiga (dapagliflozin) for the treatment of symptomatic chronic heart failure (HF) across the full spectrum of left ventricular ejection fraction (LVEF). This includes patients with HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).
The expanded indication follows a positive opinion from the Committee for Medicinal Products for Human Use in December 2022, based on results from the DELIVER Phase III trial. A pooled analysis of the DELIVER and DAPA-HF trials also established Forxiga as the first HF medication to demonstrate a mortality benefit across the entire ejection fraction range.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, stated that the broader indication will allow more patients to benefit from the treatment. "We are redefining the treatment of cardiorenal diseases with Forxiga’s demonstrated life-saving benefits," Pangalos said.
Heart failure affects approximately 15 million people in Europe, with about half of patients dying within five years of diagnosis. Patients with HFmrEF and HFpEF face a high risk of death and hospitalisation, alongside significant symptoms and reduced quality of life.
Forxiga, known as Farxiga in the United States, is already approved for type 2 diabetes, HFrEF, and chronic kidney disease in over 100 countries. Applications for the expanded HF indication are currently under review in the US and other regions.