Drugmaker AstraZeneca announced Jan. 6 that its SGLT2 inhibitor dapagliflozin, sold commercially as Farxiga, had been granted Priority Review by the FDA for patients with heart failure with reduced ejection fraction (HFrEF).
Dapagliflozin, initially approved by the FDA to improve glycemic control in adults with type 2 diabetes, has moved swiftly through the regulatory process since last fall, when John J.V. McMurray, MD, et al. published the results of the landmark DAPA-HF trial in the New England Journal of Medicine. DAPA-HF found that dapagliflozin plus standard care reduced CV death and worsening HF compared to a placebo, prompting the FDA to fast-track the drug’s development in August.
Just weeks later, in September, the FDA granted AstraZeneca another Fast Track designation, this time to develop dapagliflozin as a means to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease, with or without type 2 diabetes.
The FDA accepted AstraZeneca’s supplemental New Drug Application (sNDA) for dapagliflozin this month to reduce the risk of CV death or worsening HF in adults with HFrEF, with and without type 2 diabetes. Its decision, which included Priority Review status for the drug, was also rooted in the positive results of DAPA-HF.
“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, BioPharmaceuticals R&D, said in a statement from AstraZeneca. “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 for AstraZeneca’s supplemental application for dapagliflozin is scheduled for the second quarter of 2020.