Key Takeaways
- The FDA's efficacy and safety concerns with the confirmatory trial for AstraZeneca's Andexxa indicate the drug is unlikely to convert its accelerated approval to full approval and may face a withdrawal request.
- FDA advisory committee preview documents suggest the company may have been better positioned if it had followed the agency's 2020 advice on when to measure efficacy outcomes.
- The unmet need for anticoagulant reversal agents could help save the drug, though the FDA gave little mention of it in the preview documents. The agency also did not ask for new trial designs, another potential signal FDA does not want to keep the product on the market.
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...
The speed of a withdrawal may depend on whether the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) meeting is officially considered a session to advise the FDA on potential...