Eisai completes rolling submission to US FDA for Leqembi (lecanemab-irmb) biologics license application for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease under the fast track status

Biogen

31 October 2024 - Eisai and Biogen announced today that Eisai has completed the rolling submission of a biologics license application to the US FDA for lecanemab-irmb (Leqembi) subcutaneous auto-injector for weekly maintenance dosing after it was granted fast track designation by the FDA. 

Leqembi is indicated for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease.

Read Biogen press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier