Eisai and Biogen Seek Japanese PMDA Approval for Leqembi SC (Lecanemab) to Treat Early Alzheimer’s Disease
Shots:
- The Japanese PMDA has received NDA for Leqembi SC autoinjector to treat adults with early Alzheimer’s disease (AD)
- NDA is supported by sub-studies from the P-III (Clarity AD) OLE study in pts with mild cognitive impairment due to AD or mild AD dementia, showing that Leqembi (500mg, SC: two 250mg injections) administered QW, provided exposure equivalent to Q2W IV dosing & showed comparable clinical & biomarker benefits
- Eisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority
Ref: GlobeNewswire | Image: Eisai & Biogen | Press Release
Related News:- Eisai and BioArctic Report the MHRA Approval of Leqembi (Lecanemab) as a Maintenance Therapy to Treat Early Alzheimer’s Disease
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