AstraZeneca Forxiga approved for expanded use in EU for chronic heart failure
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The European Commission (EC) approved AstraZeneca (NASDAQ:AZN) Forxiga for expanded use to treat heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).
A panel of the European Medicines Agency (EMA) recommended the expanded approval of Forxiga (dapagliflozin) in December 2022 to treat adults with symptomatic chronic heart failure.
The EC approval was backed by data from a phase 3 trial called DELIVER.
The British pharma giant said results from the prespecified pooled analysis of DELIVER and DAPA-HF phase 3 trials also established Forxiga as the first HF medication to show mortality benefit across the full ejection fraction range.
"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, known as Farxiga in the U.S., is approved to treat patients with type-2 diabetes (T2D), HFrEF and CKD in more than 100 countries including the U.S., the EU, the company added.