The European Commission (EC) has granted approval for AstraZeneca’s Forxiga (dapagliflozin), a first-in-class, oral, once-daily SGLT2 inhibitor, to treat symptomatic chronic heart failure (HF).
Forxiga has received approval in the EU to extend the indication for HF with reduced ejection fraction (HFrEF).
It will now include patients across the complete spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).
The EC’s approval comes after the Committee for Medicinal Products for Human Use’s positive opinion in December last year.
It is based on the data obtained from the Phase III DELIVER clinical trial, which was designed for assessing Forxiga’s efficacy compared with placebo to treat HF patients with LVEF greater than 40%, with or without type-2 diabetes (T2D).
The findings from the DELIVER and Phase III DAPA-HF trials also confirmed Forxiga as the first and only HF treatment to show mortality benefit across the complete ejection fraction range.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos 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.”
Also known as Farxiga in the US, Forxiga has already received approval to treat T2D, HFrEF and CKD patients in over 100 countries globally including Japan, China, the US, and the EU.
Recently, it received regulatory approvals in Japan, Turkey, and Great Britain to extend the HF indication to include patients across the complete LVEF spectrum.
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