The European Medicines Agency's (EMA) Scientific Advisory Group (SAG) is set to convene to discuss the marketing authorization application (MAA) for lecanemab, an Alzheimer's disease treatment developed through a collaboration between BioArctic and Eisai. This review is a standard procedure for novel treatments and concepts, requested by the Committee for Medicinal Products for Human Use (CHMP) to gain independent advice on the scientific and technical aspects of lecanemab.
Eisai anticipates a decision from the European Commission regarding the MAA for lecanemab in the second quarter of 2024, contingent on a positive opinion from the CHMP following the SAG's evaluation. Lecanemab has already received approval in the United States, Japan and China for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD).
Lecanemab's Mechanism and Global Approvals
Lecanemab, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, targets aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). It is designed to slow the progression of Alzheimer's disease and reduce cognitive decline in its early stages. In the U.S., the FDA granted traditional approval to LEQEMBI (lecanemab) on July 6, 2023, as a disease-modifying treatment for Alzheimer's. Japan's Ministry of Health, Labour and Welfare (MHLW) approved lecanemab on September 25, 2023, for slowing the progression of MCI and mild dementia due to AD. Furthermore, China's National Medical Products Administration (NMPA) approved Leqembi on January 5, 2024, for treating MCI due to AD and mild AD dementia.
Collaboration and Commercialization
BioArctic and Eisai have a long-standing collaboration since 2005, focusing on developing and commercializing drugs for Alzheimer's disease. Eisai leads the clinical development, regulatory submissions, and commercialization of lecanemab globally. BioArctic retains the right to commercialize lecanemab in the Nordic region, pending European approval, and is preparing for joint commercialization with Eisai in that region. Eisai and Biogen co-commercialize and co-promote the product, with Eisai having final decision-making authority.
Ongoing Research and Future Studies
Eisai is also evaluating subcutaneous dosing of lecanemab in the Clarity AD open-label extension (OLE) study, following the completion of a subcutaneous bioavailability study. Additionally, a maintenance dosing regimen was assessed in the Phase 2b study (Study 201). The Phase 3 AHEAD 3-45 study, which began in July 2020, is investigating lecanemab in individuals with preclinical AD who have intermediate or elevated levels of amyloid in their brains. Furthermore, lecanemab is being used as the backbone anti-amyloid therapy in the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU).
