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FDA approves injectable Leqembi by end of 2024?
5
Resolution / Starting Odds
Yes • 50%
No • 50%
Official announcement by the U.S. FDA or news release from Eisai and Biogen
Story
Eisai and Biogen Begin Rolling BLA for Subcutaneous, Injectable Alzheimer's Drug Leqembi
May 15, 2024, 04:15 AM
Eisai and Biogen have initiated a rolling Biologics License Application (BLA) to the U.S. FDA for a subcutaneous, injectable version of their Alzheimer's drug, Leqembi. This submission, which had been delayed due to procedural issues, aims to provide a maintenance dosing option for early Alzheimer's disease. The application is being processed under the FDA's Fast Track status, which is designed to expedite the review of drugs that treat serious conditions and fill an unmet medical need.
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