Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher)  announced that their humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, LEQEMBI® (generic name: lecanemab), has been approved in Israel for the treatment of Alzheimer’s disease (AD). This approval is intended for patients in the mild cognitive impairment (MCI) or mild dementia stages of the disease, collectively referred to as early AD, which aligns with the populations included in clinical trials.

LEQEMBI selectively targets soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), major components of Aβ plaques, effectively reducing both in the brain. It is the first approved treatment to show a reduction in disease progression and cognitive and functional decline through this mechanism. LEQEMBI has also received approvals in the U.S., Japan, China, South Korea, and Hong Kong and is currently marketed in the U.S., Japan, and China.

The approval in Israel is based on the Phase 3 Clarity AD study, where LEQEMBI met its primary and all key secondary endpoints with statistically significant results.

Eisai leads global development and regulatory submissions for lecanemab, with both Eisai and Biogen co-commercializing and co-promoting the product. Eisai will be responsible for commercializing LEQEMBI in Israel.