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 pathologyApproval 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 2025Approval 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 &…
Shots:The EC has approved Leqembi for the treatment of early Alzheimer’s disease in all 30 EEA statesEisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it…
Shots:Michael Irizarry, Senior VP of Clinical Research and Deputy Chief Clinical Officer, Alzheimer’s Disease and Brain Health at Eisai in a stimulating conversation with PharmaShotsMichael shares insights from the P-III clinical study Clarity AD of LEQEMBI for the treatment of Alzheimer’s diseaseThe study highlights that LEQEMBI treatment met the primary endpoint and…
Shots:Michael spoke about the P-III Clarity AD study evaluating Leqembi (lecanemab) for the treatment of mild cognitive impairment due to Alzheimer’s disease presented at CTAD 2022He also talked about Eisai’s collaboration with Biogen for the co-commercialization and co-promotion of LecanemabThe interview gives an understanding of how Biogen develops and delivers innovative therapies…

