Eisai and Biogen's Alzheimer's Drug Leqembi Receives First European Approval in Great Britain

Author: Benzinga Newsdesk | August 22, 2024 05:13am

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, ", Biogen", ))))) announced today that the humanized amyloid-beta (Aβ) monoclonal antibody "Leqembi®" (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.1 Lecanemab is indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers.1 Lecanemab becomes the first treatment for early AD (MCI and mild dementia due to AD)2 that targets an underlying cause of the disease, to be authorized in a country in Europe.1

Lecanemab selectively binds to Aβ aggregate species, with preferential activity for toxic Aβ protofibrils** (as well as fibrils, which are a major component of Aβ plaques).2,3,4 It binds to these aggregate Aβ species to neutralize and clear them from the brain.2,3,4

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 (change from baseline in the Clinical Dementia Rating Sum of Boxes [CDR-SB]† at 18 months) and all key secondary endpoints with statistically significant results.2 In the indicated population in Great Britain, the most common adverse reactions were infusion-related reaction, amyloid-related imaging abnormalities with hemorrhage (small spots of bleeding) (ARIA-H)‡, fall, headache and amyloid-related imaging abnormalities with cerebral edema (build-up of fluid) (ARIA-E)‡‡.1 

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