Biogen, Eisai eye fiscal 2025 U.S. approval for home version of Alzheimer's drug

 Eisai and Biogen announced that the FDA has accepted their Biologics License Application (BLA) for LEQEMBI subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease treatment. The PDUFA action date is set for August 31, 2025.

If approved, LEQEMBI will be the only Alzheimer's treatment offering subcutaneous administration at home via autoinjector, with injections taking approximately 15 seconds. The treatment would require completion of an initial biweekly intravenous phase before transitioning to weekly subcutaneous maintenance doses.

LEQEMBI is currently approved in multiple countries including the US, Japan, China, and received a positive CHMP opinion in Europe. The FDA is also reviewing a separate application for monthly IV maintenance dosing with a PDUFA date of January 25, 2025.

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