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…

ByRidhi RastogiNovember 28, 2025

Eisai and BioArctic Report the MHRA Approval of Leqembi (Lecanemab) as a Maintenance Therapy to Treat Early Alzheimer’s Disease

Shots: The UK’s MHRA has approved Leqembi (IV, Q4W) as a maintenance therapy for early Alzheimer’s pts after completing 18mos. of Q2W Leqembi treatment Leqembi is approved in 51 countries for early AD & under review in 9, while the Q4W maintenance is approved in the UK, China, the US, & others, with 4 applications…

ByRidhi RastogiNovember 14, 2025

Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Shots: Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…

ByRidhi RastogiOctober 27, 2025

Eisai and Biogen Seek Japanese PMDA Approval for Leqembi SC (Lecanemab) to Treat Early Alzheimer’s Disease

Eisai and BioArctic Report the MHRA Approval of Leqembi (Lecanemab) as a Maintenance Therapy to Treat Early Alzheimer’s Disease

Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

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