Shots:
- The MHLW has approved Leqembi Pen (SC autoinjector) administered as 500mg given QW as two pens, each delivered in ~15secs, for the treatment of early Alzheimer’s disease
- Approval was supported by 18mos. P-III Clarity AD data in pts with mild cognitive impairment (MCI) due to AD or mild AD dementia & multiple SC administration sub-studies, with SC 500mg (QW) showing equivalent exposure to IV dosing (Q2W)
- Eisai leads global development & regulatory submissions, co-commercializes the product with Biogen, & retains final decision-making authority
Ref: Globenewswire | Image: Biogen & Eisai | Press Release
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