FDA Grants Dapagliflozin Priority Review for Heart Failure, Even for Those Without Diabetes

January 9, 2020
Mary Caffrey

Priority review was based on phase 3 results from DAPA-HF, presented in Paris at the European Society of Cardiology and published in the New England Journal of Medicine.

The FDA this week granted priority review status to the supplemental new drug application (sNDA) for dapagliflozin to reduce the risk of cardiovascular (CV) death or worsening of heart failure regardless of diabetes status. Dapagliflozin is sold as Farxiga by AstraZeneca.

Priority review status was based on results of the phase 3 DAPA-HF trial, which was presented in Paris at the European Society of Cardiology and published in the New England Journal of Medicine. Those results showed taking the sodium glucose co-transporter 2 (SGLT2) inhibitor reduced the risk of CV death or heart failure hospitalization and urgent care measures by 26%.

Of note, the outcomes were the same for patients with and without type 2 diabetes. Benefits were substantial for at-risk patients without prior hospitalization, who saw a 33% risk reduction, as well as those who were obese, who saw a 31% risk reduction.

“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 for AstraZeneca BioPharmaceuticals Research and Development, said in a statement. “If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”

The news follows the FDA’s announcement in September that dapagliflozin had received Fast Track designation in heart failure. In August, dapagliflozin received Fast Track designation for the prevention of renal failure and CV and renal death in patients with chronic kidney disease, regardless of diabetes status.

In October, the FDA approved dapagliflozin to reduce the risk of hospitalization for heart failure in patients with T2D and established cardiovascular disease or multiple CV risk factors. This was based on results of DECLARE-TIMI, the cardiovascular outcomes trial required by the FDA of new glycemic-lowering therapies; results were reported in November 2018.