AstraZeneca’s Andexxa Could Be Headed For Withdrawal After US FDA’s Negative Advisory Committee Preview

 
• By Sarah Karlin-Smith

The confirmatory trial for the anticoagulant reversal agent raised safety and efficacy concerns from the agency.

exit painted on pavement.
A negative 21 November advisory committee recommendation could portend a marketing exit for Andexxa. (Shutterstock)

AstraZeneca PLC’s Andexxa may face withdrawal after the US Food and Drug Administration raised concerns about its clinical efficacy, as well as serious safety events seen in the anticoagulant reversal agent’s confirmatory study in briefing documents ahead of a 21 November advisory committee.

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