FDA approves AstraZeneca drug for heart failure risk

(Sharecast News) - AstraZeneca on Monday announced that its Farxiga treatment against heart failure risk in certain patient groups has received approval from the US Food and Drug Administration.


Adult patients with type-2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors will be able to receive the treatment, which has gained approval on the back of results from a Declare-Timi 58 cardiovascular outcomes trial that evaluated these groups of patients.

Farxiga is a first-in-class, oral once-daily treatment that can be used as both monotherapy and as part of combination therapy to improve glycaemic control..

The treatment has 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years' experience.

BioPharmaceuticals executive vice president Ruud Dobber said: "This is promising news for the 30 million people living with type-2 diabetes in the US, as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalisation for heart failure."

The treatment has received marketing authorisation in the European Union and is currently under regulatory review in China, with a decision anticipated in the first half of next year.

AstraZeneca shares were down by 0.34% at 6,749.00p at 0808 BST.