U.S. FDA approves AstraZeneca diabetes drug for treating heart failure risk

AstraZeneca's (AZN.L) diabetes drug Farxiga has been approved for use in the United States as a treatment to reduce the chances of hospitalisation for heart failure in adults with type-2 diabetes and other cardiovascular risks, the British drugmaker said on Monday.

The approval by the U.S. Food and Drug Administration is based on results from the DECLARE-TIMI 58 clinical trial, the London-listed company said, and follows a similar approval here by the European authorities in August.

Farxiga is the first of its class to be approved in the United States for this indication, Ruud Dobber, executive vice president of BioPharmaceuticals at AstraZeneca said.

"This is promising news for the 30 million people living with type-2 diabetes in the United States, as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke," Dobber said.

Farxiga, already approved as a treatment for type-2 diabetes, is part of the SGLT2-inhibitor class of antidiabetics that cause the kidneys to expel blood sugar from the body through urine.

Diabetes is often associated with a high risk of heart failure, a condition in which the blood-pumping organ does not circulate blood as well as it should.

The treatment, one of AstraZeneca's top 10 drugs by sales, had shown promise in reducing the risk of heart attacks or disease progression in patients with the HFrEF subtype of heart failure, accounting for about half of heart failure cases.

The FDA has already placed Farxiga under speedy reviews to treat some kinds of heart failure and kidney failure.