Three months after it won approval in type 2 diabetes, AstraZeneca’s Farxiga is eying potential regulatory win as a treatment in heart failure patients.

The U.S. Food and Drug Administration (FDA) granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D). Although no hard date was provided for a ruling, AstraZeneca said the Prescription Drug User Fee Act date is set for the second quarter of 2020. Priority Review narrows the 12-month window of time the FDA typically takes to approve a drug following the submission of a New Drug Application. The designation typically cuts the time almost in half.

AstraZeneca’s supplemental New Drug Application was based on the results of the Phase III DAPA-HF and DELIVER trial that showed how the drug decreased the risk of heart failure. Approximately 40% of patients who participated in the trial had type 2 diabetes, a condition common among heart failure patients. The promise of Farxiga in this indication earned the SGLT2 inhibitor Fast Track designation from the FDA for heart failure. The FDA also granted Fast Track designation for the development of Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease, with and without type 2 diabetes.

Mene Pangalos, head of biopharmaceuticals R&D at AstraZeneca, said Farxiga is well-established as a treatment in type 2 diabetes and the Priority Review from the FDA confirms its potential as a benefit for millions of people who have heart failure.

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

In October, the FDA approved Farxiga to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. That approval was granted based on results from the landmark DECLARE-TIMI 58 CV outcomes trial, which evaluated type 2 diabetes patients with multiple cardiovascular risk factors or established cardiovascular disease. Farxiga has previously been approved as a monotherapy and as a combination treatment to improve blood sugar control in type 2 diabetes. Farxiga won a similar approval in the European Union in August. A decision for this indication is expected in China in the first half of 2020.



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