FDA approves dapagliflozin for HFrEF regardless of diabetes status
AstraZeneca announced the FDA has approved its SGLT2 inhibitor dapagliflozin to reduce risk for CV death and HF hospitalization in patients with HF with reduced ejection fraction with and without type 2 diabetes.
Dapagliflozin (Farxiga) is the first SGLT2 inhibitor approved to treat patients with HFrEF, or a left ventricular ejection fraction less than 40%, according to a press release from the company.
“It is clearly important to obtain regulatory approval for the new indication in patients with heart failure who do not have diabetes,” John McMurray, MD, professor of cardiology at the Institute of Cardiovascular and Medical Sciences at University of Glasgow in Scotland, told Healio. “Now, literally millions of Americans can be considered for treatment with a new lifesaving treatment.”
The FDA approval of dapagliflozin was based on positive results from the DAPA-HF trial. As Healio previously reported, treatment with dapagliflozin reduced worsening HF and CV death when added to standard therapy. During a median follow-up of 18.2 months, the primary outcome of CV death or worsening HF was reduced by 26% in the group assigned dapagliflozin compared with those assigned placebo (16.3% vs. 21.2%; HR = 0.74; 95% CI, 0.65-0.85; number needed to treat = 21).
“[Patients with HFrEF] have a new treatment that works in a different way than any other treatment for heart failure, and the DAPA-HF trial shows it does everything the ideal heart failure drug should do — improve symptoms, reduce hospital admissions, increase survival, and be easy to take and well tolerated,” McMurray said in an interview.
The decision regarding this approval followed a fast track designation in September and a priority review designation in January, according to the release. Dapagliflozin was approved by the FDA in October for the reduction of HF hospitalization in patients with type 2 diabetes and multiple CV risk factors or established CVD.
“With the approval of Farxiga, we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with the condition in the U.S.,” Mene Pangalos, executive vice president of biopharmaceuticals research and development for AstraZeneca, said in the release. “We are now one step closer to making a significant impact on their lives by providing a much-needed treatment to help reduce their disease burden and live longer.” – by Darlene Dobkowski
For more information:
John McMurray, MD, can be reached at Research and Innovation Services, 11 The Square, University of Glasgow, G12 8QQ, United Kingdom.
Disclosures: The DAPA-HF trial was funded by AstraZeneca. McMurray reports his institution was paid by AstraZeneca for his role as principal investigator in the DAPA-HF trial. Pangalos is an employee of AstraZeneca.