FDA expands dapagliflozin indication to reduce heart failure hospitalization
The diabetes drug dapagliflozin has been approved by the FDA to reduce the risk for heart failure hospitalization among adults with type 2 diabetes who also have cardiovascular disease or multiple CV risk factors, according to a press release from AstraZeneca.
The approval is based on results of the DECLARE-TIMI 58 trial. As Healio previously reported, that trial, which included more than 17,000 patients with type 2 diabetes who were followed for a median of 4.2 years, demonstrated a 27% reduction in the rate of hospitalization for heart failure among participants assigned the SGLT2 inhibitor dapagliflozin (Farxiga) vs. those assigned placebo (HR = 0.73; 95% CI, 0.61-0.88).
The approval “is promising news for the 30 million people living with type 2 diabetes in the U.S., as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure,” Ruud Dobber, AstraZeneca executive vice president, BioPharmaceuticals Business Unit, said in the release.
Dapagliflozin is approved in the U.S. as monotherapy and as part of combination therapy to improve glycemic control for patients with type 2 diabetes. However, the FDA and the company are exploring its use among adults without diabetes.
In September, the FDA granted fast track designation to dapagliflozin for reducing the risk for CV death or worsening heart failure among adults with heart failure with reduced or preserved ejection fraction. That designation was based on two different trials: DAPA-HF and DELIVER. In DAPA-HF, dapagliflozin added to standard therapy for heart failure was associated with reduced risk for worsening heart failure and CV death for patients with heart failure with and without diabetes.
In August, the FDA granted fast track designation for dapagliflozin for use in patients with or without diabetes who have chronic kidney disease to delay progression of renal failure and to prevent cardiovascular and renal death. – by Jill Rollet
Disclosure: Dobber is executive vice president, BioPharmaceuticals Business Unit at AstraZeneca.