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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 diseaseÂ
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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The post Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease appeared first on PharmaShots.
Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease | PharmaVoice