Key Takeaways
- Andexxa will not convert to a full approval after the US FDA sent AstraZeneca a complete response letter, but it is unclear whether the agency will try to withdraw the drug from the market.
- The FDA has acknowledged the need to be more transparent about its actions when confirmatory trials produce disappointing results and more proactive in addressing dangling accelerated approvals.
- Andexxa, which is known as Ondexxya in the EU, saw its conditional approval renewed for a year in March, but it is unclear whether the timing of the reauthorization gave the EU an opportunity to review the confirmatory trial results.
AstraZeneca PLC’s anticoagulant reversal agent Andexxa (andexanet) will not convert to full approval, the company told the Pink Sheet after the US Food and Drug Administration issued a...
The next steps for the drug following the CRL, which has not been publicly announced by the company, are unclear. Neither AstraZeneca nor FDA would provide much additional information about...
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