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…
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…
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 &…

