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…
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…
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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 &…
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 PharmaShots
Michael shares insights from the P-III clinical study Clarity AD of LEQEMBI for the treatment of Alzheimer’s disease
The study highlights that LEQEMBI treatment met the primary endpoint and…
Shots:
Michael talked about the new data from its Alzheimer’s pipeline at the Alzheimer’s Association International (AAIC)
Michael also highlighted the study design of the P-II & P-III trial evaluating lecanemab
The interview gives an understanding of Eisai’s human health care (hhc) concept which provides innovative products with high unmet medical needs to target diseases…

