FDA expands dapagliflozin approval to cover all heart failure patients
AstraZeneca has announced that dapagliflozin, which it sells under the name Farxiga, is now approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF, in all adult HF patients.
The SGLT2 inhibitor had already been approved for reducing those risks, but only in patients with HF with reduced ejection fraction (HFrEF).
“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,” Ruud Dobber, PhD, executive vice president of AstraZeneca’s biopharmaceuticals business unit, said in a prepared statement. The approval of Farxiga in the U.S. 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.”
Dapagliflozin was also previously approved to treat both type 2 diabetes and chronic kidney disease. It is not recommended for patients with type 1 diabetes, however, because it could increase their risk of diabetic ketoacidosis.
According to AstraZeneca, this new expansion of the FDA’s approval is based in part on data from the DELIVER Phase III trial. Originally published in New England Journal of Medicine, the study determined that dapagliflozin was associated with a significant reduction in the composite endpoint of cardiovascular death or worsening HF among patients with HF, HF with mildly reduced ejection fraction (HFmrEF) or HF with preserved ejection fraction (HFpEF).
“These data provide further evidence to support the use of an SGLT2 inhibitor as essential therapy in patients with heart failure, regardless of the presence or absence of type 2 diabetes mellitus or left ventricular ejection fraction,” the authors concluded at the time.
Additional studies exploring the potential impact of dapagliflozin among HF patients have been published in Nature Medicine and the Journal of the American College of Cardiology.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.