The US Food and Drug Administration (FDA) has granted approval for AstraZeneca’s Farxiga (dapagliflozin) to reduce the risks of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) emergency care visits in HF adult patients.
The regulator approved Farxiga in 2020 for reducing the risk of hHF and CV death in HF adult patients with reduced ejection fraction (HFrEF).
AstraZeneca BioPharmaceuticals executive vice-president Ruud Dobber stated: “Approximately half of heart failure patients die within five years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring life-saving benefits and reduce the risk of cardiovascular death.
“The approval of Farxigain in the US not only reinforces AstraZeneca’s commitment to reducing the burden of this complex and life-threatening disease but will help patients across the full spectrum of heart failure lead healthier lives.”
The latest regulatory approval was based on data obtained from the DELIVER Phase III trial.
This parallel-group, event-driven, randomised, placebo-controlled, double-blind, international Phase III trial was designed to assess Farxiga’s efficacy against a placebo to treat HF patients with left ventricular ejection fraction greater than 40%, with or without type 2 diabetes (T2D).
Farxiga showed a statistically significant and clinically meaningful early reduction in the primary composite endpoint of CV death or worsening HF in patients suffering heart failure with mid-range ejection fraction (HFmrEF) or with preserved ejection fraction (HFpE).
It has been approved in more than 100 countries and regions, including China, Japan, the US and the European Union (EU), to treat T2D HFrEF and chronic kidney disease patients.