(Alliance News) - FTSE 100-listed drug maker AstraZeneca PLC said Monday its blockbuster Farxiga treatment has been approved in the US to reduce the risk of heart failure hospitalisation for diabetes patients.
Farxiga - the brand name of dapagliflozin - has been approved by the US Food & Drug Administration in order to reduce the risk of hospitalisation for heart failure of adults with type-two diabetes as well as established cardiovascular disease or multiple cardiovascular risk factors.
The approval follows the DECLARE-TIMI 58 CV outcomes trial which evaluated type-two diabetes patients with multiple CV risk factors.
"Farxiga is the first SGLT2 [sodium-glucose cotransporter two] inhibitor approved in the US to reduce the risk of hospitalisation for heart failure in type-2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors," AstraZeneca Bio pharmaceuticals Business Unit Vice President Rood 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," Dobber added. "Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalisation for heart failure."
Farxiga remains under regulatory review in China. A decision is expected in the first half of 2020.
Shares in AstraZeneca were 0.6% lower at 6,731.00 pence in London on Monday.
By Ahren Lester; ahrenlester@alliancenews.com
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