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Global expansion of injectable Leqembi post-FDA approval
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Corporate announcements from Eisai and Biogen, international health regulatory updates
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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