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 the risks appeared to outweigh the benefits in the sponsor’s confirmatory trial, but that those results were only applicable to a portion of the drug’s indication.
AstraZeneca’s Andexxa May Continue Dangling In Accelerated Approval After Mixed Advisory Panel
The Cellular, Tissue and Gene Therapies Advisory Committee appeared unsatisfied with the risk-benefit balance of the anticoagulant reversal agent in the confirmatory trial, but was not ready to throw out the product, suggesting new trials may be needed.
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