FDA panel flags risks as AstraZeneca seeks full Andexxa approval

British pharma major AstraZeneca (LSE: AZN) is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA.

During an advisory committee meeting on Thursday, experts raised significant concerns about the drug's safety profile and questioned whether its benefits sufficiently outweigh the risks.

While no formal votes were taken, and the US Food and Drug Administration is not obliged to follow the advice of its committee, the input is often a strong indication of future regulatory decisions.