Leqembi®∇ (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union

Core Insights - Lecanemab has received Marketing Authorization in the EU, marking it as the first therapy targeting the underlying cause of Alzheimer's disease to be approved in this region [1][2][6] - The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease who are non-carriers or heterozygotes of the ApoE ε4 gene [1][2][6] - The approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway [1][2] Company Overview - Eisai and Biogen are collaborating on the development and commercialization of lecanemab, with Eisai leading global regulatory submissions and having final decision-making authority [2][10] - The approval of lecanemab in the EU is the thirteenth approval globally, following its success in the U.S., Japan, and other regions [2][6] - Eisai aims to work with national reimbursement authorities to ensure access to lecanemab for eligible patients as soon as possible [2] Clinical Data - The authorization was based on Phase 3 data from the Clarity AD clinical trial, which involved 1,795 patients and demonstrated a 31% reduction in clinical decline on the CDR-SB scale at 18 months compared to placebo [6][7] - The trial showed that lecanemab reduced the mean change from baseline on the CDR-SB score by 0.535 points compared to placebo [6][7] - Secondary endpoints indicated a 33% less decline in the ADCS MCI-ADL score for lecanemab compared to placebo at 18 months [7] Market Context - Alzheimer's disease currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with mild dementia in Europe, highlighting a significant unmet need for effective treatments [1][2][6] - Lecanemab is positioned as a groundbreaking treatment in a field that has seen little innovation over the past two decades [2][6] Safety Profile - Common adverse reactions reported in the clinical trial included infusion-related reactions (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%) [7] - The treatment is subject to additional monitoring to quickly identify new safety information [4]