AstraZeneca to Halt Andexxa Sales in US Over FDA Safety Concerns

MT Newswires Live12-20

AstraZeneca (AZN) will halt US sales of Andexxa by Monday, following warnings from the US Food and Drug Administration that the drug's risks, including serious thromboembolic events, outweigh its benefits, the health regulator said Thursday.

Following discussions with the FDA, AstraZeneca requested voluntary withdrawal of Andexxa's biologics license application and confirmed that US sales and manufacturing will end after Dec. 22.

The ANNEXA-I trial showed higher rates of thrombosis and related deaths compared with usual care, prompting regulatory concern, the FDA said.

The FDA added it will continue to monitor safety and coordinate with AstraZeneca to update healthcare providers and the public during Andexxa's withdrawal.

AstraZeneca did not immediately reply to MT Newswires' request for comment.

Shares of the company were up almost 1% in recent Friday trading.

Price: 91.50, Change: +0.89, Percent Change: +0.98

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