Key Takeaways
- No votes were taken during the advisory committee meeting, but members suggested the confirmatory trial for AstraZeneca’s anticoagulant reversal agent Andexxa did not demonstrate a clinical benefit and had an unfavorable risk-benefit profile.
- But panelists indicated the confirmatory trial was conducted in only a subset of the patients indicated in the product's 2018 accelerated approval and did not feel the risk-benefit profile from the trial was applicable to the other indicated populations.
- The committee did not seem over eager to pull the drug from the market, which may suggest more testing of the drug and another shot at converting the accelerated approval to full approval.
AstraZeneca PLC may need more studies to convert its anticoagulant reversal agent Andexxa (andexanet) from accelerated to full approval, after an advisory committee raised concerns that...
No votes were taken during the 21 November Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC). Despite the negative risk-benefit balance in the confirmatory trial, ANNEXA-I, committee members seemed inclined...
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