Shots:
- The NMPA has approved Leqembi (SC autoinjector/SC-AI) as an initiation dose administered as 500mg given QW as two consecutive 250mg injections, each delivered in ~15secs, for the treatment of early Alzheimer’s disease
- Approval was supported by 18mos. P-III Clarity AD data & multiple SC administration sub-studies (incl. Chinese cohort), with SC-AI 500mg (QW) showing equivalent exposure to IV dosing (Q2W) & similar clinical and biomarker benefits
- Leqembi (SC-AI) launch is expected in the China during Eisai’s FY’26, ending Mar 31, 2027. Eisai leads global development & regulatory submissions, co-commercializes the product with Biogen, & retains final decision-making authority; Eisai will distribute the product in China
Ref: Globenewswire | Image: Biogen & Eisai | Press Release
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