TOKYO and CAMBRIDGE, Mass., July 26, 2024 (GLOBE NEWSWIRE) -- 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).1
“We are extremely disappointed by the CHMP’s negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease (AD) community. AD is an irreversible, neurodegenerative disease that poses significant challenges to those living with AD, their care partners and society,” said Lynn Kramer, M.D., Chief Clinical Officer at Eisai. “There is a significant unmet need for new innovative treatment options that target an underlying cause of disease progression. We remain focused on making a meaningful difference to those living with early AD and those closest to them.”
Eisai will seek re-examination of the CHMP opinion and work with the relevant authorities to ensure this treatment is available for eligible people living with early AD in the European Union (EU) as soon as possible.
Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong and Israel, and is being marketed in the U.S., Japan and China.
AD currently affects 6.9 million people in Europe,2 and this figure is expected to nearly double by 2050 as aging populations increase.3
Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
| MEDIA CONTACTS | |
| Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Europe, Ltd. EMEA Communications Department+44 (0) 786 601 1272Emea-comms@eisai.netEisai Inc. (U.S.)Libby Holman+1-201-753-1945Libby_Holman@eisai.com | Biogen Inc.Jack Cox+ 1-781-464-3260public.affairs@biogen.com |
| INVESTOR CONTACTS | |
| Eisai Co., Ltd.Investor Relations DepartmentTEL: +81 (0) 3-3817-5122 | Biogen Inc.Chuck Triano+ 1-781-464-2442IR@biogen.com |
Notes to Editors
- About lecanemab (generic name, brand name: Leqembi®)Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel for the treatment of MCI due to AD and mild AD dementia. Lecanemab’s approvals in these countries were based on Phase 3 data from Eisai’s, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.4,5 The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.4 The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P