Eisai And Biogen : Leqembi Approved In Great Britain For Early Alzheimer's Disease

(RTTNews) - Eisai Co., Ltd. (ESALY.PK) and Biogen Inc. (BIIB) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain has granted Marketing Authorization for Leqembi (lecanemab), a humanized amyloid-beta monoclonal antibody.

Lecanemab is approved for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease in adult patients that are apolipoprotein E e4 heterozygotes or non-carriers.

The approval was primarily based on Phase 3 data from Eisai's global, placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which the medicine met its primary endpoint and all key secondary endpoints with statistically significant results.

Eisai noted that the Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of Alzheimer's disease.

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