US Food and Drug Administration approval for Eli Lilly and Company’s donanemab has been delayed for a third time now that the agency has decided to convene a meeting of its Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial results for the anti-amyloid antibody in early Alzheimer’s disease. Lilly expected approval during the first quarter of 2024 but said on 8 March that this is no longer likely.
Key Takeaways
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After the US FDA declined to grant accelerated approval for Lilly’s donanemab and pushed out the action date for potential full approval last year, the agency again delayed its decision because it wants to convene an advisory committee meeting.
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The committee will likely meet in the second quarter, missing Lilly’s guidance that donanemab would be approved in the first quarter
This is the third time that donanemab’s approval has been pushed back, starting with the FDA’s decision to issue a complete response letter in January 2023 rather than grant accelerated approval for the drug based on the Phase II TRAILBLAZER-ALZ clinical trial. (Also see "US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s" - Scrip, 20 January, 2023
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