Shots:
- Eisai & Biogen have reported EU launch of Leqembi, starting with Austria on Aug 25, 2025 & Germany on Sep 1, 2025, following EC approval in Apr 2025
- Approval was based on the P-III (Clarity AD) trial assessing Leqembi (n=757) vs PBO (n=764) in pts with MCI or mild dementia due to AD & amyloid pathology, where Leqembi (10g/kg Q2W) reduced clinical decline on CDR-SB by 31% at 18mos.
- Eisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it as MA Holder in all regions
Ref: Biogen | Image: Eisai & Biogen | Press Release
Related News:- Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease
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