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FDA accepts filing of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease – Eisai + Biogen

Written by | 26 Jun 2024

Eisai Co. Ltd. and Biogen Inc. announced that that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: Leqembi) intravenous (IV)… read more.

Eisai initiates rolling biologics license application to FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease under the Fast Track status

Written by | 27 May 2024

-Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab-irmb (U.S. brand name:Leqembi)… read more.

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