AstraZeneca's Andexxa Faces Potential Withdrawal After FDA Advisory Committee Concerns

Key Insights

• The FDA advisory committee preview raised significant safety and efficacy concerns regarding AstraZeneca's Andexxa.
• A negative recommendation from the advisory committee on November 21st could lead to the withdrawal of Andexxa from the market.
• The confirmatory trial for Andexxa, an anticoagulant reversal agent, prompted the FDA's scrutiny and potential marketing exit.

AstraZeneca's Andexxa (andexanet alfa), an anticoagulant reversal agent, is facing potential market withdrawal following a negative preview from the U.S. Food and Drug Administration (FDA) advisory committee. The concerns stem from the confirmatory trial data, which raised questions about the drug's safety and efficacy. A negative recommendation from the advisory committee on November 21 could signal the end of Andexxa's availability in the market. The FDA's scrutiny focuses on data submitted to confirm the clinical benefit and safety profile initially observed during Andexxa's accelerated approval process.