Eisai and Biogen announced that Lecanemab has been approved in Mexico for the treatment of early Alzheimer's disease. The approval by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) marks a significant step in addressing the growing concern of Alzheimer's in Mexico, where an estimated 1.3 million individuals are affected.
Lecanemab, a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, is designed to selectively bind to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are major components of Aβ plaques. By reducing both Aβ protofibrils and Aβ plaques in the brain, Lecanemab aims to slow the rate of disease progression and cognitive decline.
Clinical Trial Data
The approval of Lecanemab is supported by data from the Phase 3 Clarity AD study, a large global clinical trial. The study met its primary endpoint and all key secondary endpoints with statistically significant results, demonstrating the drug's potential to modify the course of Alzheimer's disease in its early stages.
Mechanism of Action
Lecanemab's mechanism involves targeting and neutralizing amyloid-beta protofibrils, which are considered the most toxic form of Aβ. These protofibrils contribute to neuronal injury and cognitive dysfunction by increasing the development of insoluble Aβ plaques and directly damaging brain cell membranes. By reducing protofibrils, Lecanemab aims to prevent the progression of Alzheimer's disease.
Commercialization and Collaboration
Eisai serves as the lead in the development and regulatory submissions for Lecanemab globally. Eisai and Biogen co-commercialize and co-promote the product, with Eisai holding final decision-making authority. This collaboration extends to Mexico, where both companies will work together to make Lecanemab available to patients.
Global Approvals and Ongoing Studies
Lecanemab is already approved and marketed in the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain. It is also under regulatory review in 16 other countries and regions, including the European Union, where it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in November 2024.
Eisai is also conducting a Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD and the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), further exploring the potential of Lecanemab in treating Alzheimer's disease.
