travellinglight/iStock via Getty Images Biogen ( NASDAQ: BIIB ) and its Japanese partner Eisai’s ( OTCPK:ESALF ) ( OTCPK:ESAIY ) breakthrough Alzheimer's therapy, Leqembi (lecanemab), has been granted marketing authorization in Great Britain, the companies announced on Thursday. Great Britain becomes the first country in Europe to authorize the drug, which targets an underlying cause of Alzheimer's disease. The approval was primarily based on Phase 3 data from Eisai's Clarity AD clinical trial, in which the drug achieved its primary endpoint and all key secondary endpoints with statistically significant results.
Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody and said to be the only approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in Alzheimer's. In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. China approved Leqembi in January 2024 as a treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease, becoming the third country to do so after the U.
S. and Japan. Eisai ( OTCPK:ESALF ) ( OTCPK:ESAIY ) is the lead developer of the drug, with Biogen ( BIIB ) assisting its commercialization.
The companies will co-promote the drug in Great Britain, with Eisai distributing the product as the marketing authorizat.