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Market
Will FDA approve LEQEMBI subcutaneous treatment by August 31, 2025?
4
Resolution / Starting Odds
Yes • 50%
No • 50%
FDA official announcement and press releases
Story
FDA Accepts Biogen and Eisai's LEQEMBI BLA for Subcutaneous Alzheimer's Treatment, PDUFA Date Set
Jan 15, 2025, 01:48 PM
The U.S. Food and Drug Administration (FDA) has accepted Biogen Inc. and Eisai Co. Ltd.'s Biologics License Application (BLA) for LEQEMBI (lecanemab-irmb), a treatment for early Alzheimer's disease, with a PDUFA action date set for August 31, 2025. The application seeks approval for a subcutaneous autoinjector (SC-AI) for weekly maintenance dosing, allowing for at-home administration. This development follows the announcement by Biogen and Eisai of the completion of the filing submission with the FDA.
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Similar markets
FDA only • 25%
Neither • 25%
Both FDA and EMA • 25%
EMA only • 25%
Approved in USA only • 25%
Not approved in USA or EU • 25%
Approved in both USA and EU • 25%
Approved in EU only • 25%
