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AstraZeneca said its type-2 diabetes drug was approved by US regulators to reduce the risk of hospitalisation for heart failure in adults with type-2 diabetes and established cardiovascular disease.
The approval comes on the back of results from the Declare-Timi 58 cardiovascular outcomes trial (CVOT), to evaluate type-2 diabetes (T2D) patients with multiple CV risk factors or established CV disease.
'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,' said Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit.