BRIEF—New US approval for Farxiga heart failure in patients with type-2 diabetes

AstraZeneca today announced that the US Food and Drug Administration as approved Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

The approval is based on results from the landmark DECLARE-TIMI 58 CV outcomes trial (CVOT), the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CVOT conducted to date to evaluate T2D patients with multiple CV risk factors or established CV disease.

Today’s US FDA approval follows the update to the marketing authorisation in the EU in  August 2019. Farxiga is also under regulatory review in China with a decision anticipated in the first half of 2020.

Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, said: “Farxiga is the first SGLT2 inhibitor approved in the US to reduce the risk of hospitalization for heart failure in type-2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors. 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 hospitalization for heart failure.”