FDA grants priority review to dapagliflozin for HFrEF treatment
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AstraZeneca announced that the SGLT2 inhibitor dapagliflozin has been granted priority review from the FDA to reduce the risk for CV mortality or worsening HF in patients with HF with reduced ejection fraction with and without type 2 diabetes.
Acceptance of the supplemental new drug application was based on results from the DAPA-HF trial presented at the European Society of Cardiology in 2019, according to a press release from the company. As Healio previously reported, 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 (Farxiga) compared with those assigned placebo (16.3% vs. 21.2%; HR = 0.74; 95% CI, 0.65-0.85; number needed to treat = 21).
Fast track designation was granted by the FDA for worsening HF in September and to delay renal failure progression and to prevent renal and CV death in patients with chronic kidney disease with and without type 2 diabetes in August, according to the release.
“Farxiga is well established in the treatment of type 2 diabetes, and this priority review shows its potential to also impact millions of patients with heart failure,” Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca, said in the release. “If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”
The Prescription Drug User Fee Act date is currently scheduled for the second quarter of 2020, according to the release.
Disclosure: Pangalos is an employee of AstraZeneca.