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Leqembi® (lecanemab) launched in the EU today
BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the launch of Leqembi in the EU started in Austria on August 25, 2025, and will be launched in Germany on September 1, 2025. Leqembi received the European Commission (EC) approval in April 2025 as the first therapy that targets an underlying cause of Alzheimer's disease (AD). It is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to A
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[{"type":"text","content":"STOCKHOLM, Aug. 25, 2025 /PRNewswire/ --BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the launch of Leqembi in the EU started in Austria on August 25, 2025, and will be launched in Germany on September 1, 2025. Leqembi received the European Commission (EC) approval in April 2025 as the first therapy that targets an underlying cause of Alzheimer's disease (AD). It is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who are apolipoprotein E ε4 (ApoE ε4[1]) non-carriers or heterozygotes with confirmed amyloid pathology.[i] Germany and Austria will mark the first launches in the EU.","length":733,"tagName":"p"},{"type":"text","content":"Following the EC approval, Eisai has been collaborating with the regional and local healthcare authorities to implement the mandatory authorisation requirements ahead of launch. The required controlled access program[2] is now in place in Austria and Germany, enabling the launch in these first two EU countries.","length":312,"tagName":"p"},{"type":"text","content":"Alzheimer's disease is a progressive, relentless disease with Aβ and tau as hallmarks. It progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that slow the progression of Alzheimer's disease from its early stage and reduce the overall burden on people affected by Alzheimer's disease and society. Only Leqembi fights Alzheimer's disease in two ways - targeting both amyloid plaque and protofibrils[3], which can impact tau accumulation downstream.","length":648,"tagName":"p"},{"type":"text","content":"In the Clarity AD clinical trial, the primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating – Sum of Boxes (CDR-SB).i Treatment with lecanemab (n=757), in the EU indicated population (ApoE ε4 non-carriers or heterozygotes, measured by controlled-based multiple imputation[4]), reduced clinical decline on CDR-SB by 31% at 18 months compared to placebo (n=764).i","length":396,"tagName":"p"},{"type":"text","content":"In the EU indicated population (ApoE ε4 non-carriers or h...