AstraZeneca Forxiga approved in EU for treatment of symptomatic chronic heart failure
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor.;
UK: AstraZeneca has recently announced that Forxiga (dapagliflozin) has been approved in the European Union to extend the indication for 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).
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use in December 2022 and was based on the positive results from the DELIVER Phase III trial. Results from the prespecified pooled analysis of DELIVER and DAPA-HF Phase III trials also established Forxiga as the first HF medication to demonstrate mortality benefit across the full ejection fraction range.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “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. We are redefining treatment of cardiorenal diseases with Forxiga’s demonstration of life-saving benefits, underscoring AstraZeneca’s commitment to provide innovative solutions that can help address the complexities of heart failure across the spectrum of the disease.”
Read also: AstraZeneca Forxiga recommended for nod in EU for chronic heart failure
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