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Market
Will Biogen and Eisai launch LEQEMBI subcutaneous treatment commercially by end of 2025?
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Resolution / Starting Odds
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Biogen and Eisai official press releases and financial reports
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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No • 50%
Yes • 50%
Yes, a new software or service • 25%
No new product/service • 25%
Yes, both an imaging agent and software/service • 25%
Yes, a new imaging agent • 25%
No • 50%
Yes • 50%
