#Mexico #Mexico City #Leqembi #BioArctic #Alzheimer's

Leqembi® Approved in Mexico for Early Alzheimer's Disease

On December 5, 2024, BioArctic AB's partner Eisai announced a significant advancement in Alzheimer's disease treatment as Leqembi® (lecanemab) received approval from Mexico's Federal Commission for the Protection Against Sanitary Risk (COFEPRIS). Leqembi® is a groundbreaking treatment that offers hope to those in the early stages of Alzheimer's disease by reducing the rate of cognitive and functional decline.

What is Leqembi®?

Leqembi® is a monoclonal antibody that selectively binds to aggregated forms of amyloid-beta (Aβ) in the brain, targeting both soluble (protofibrils) and insoluble Aβ aggregates (fibrils). Its unique mechanism helps reduce these aggregates, which are a significant component of Alzheimer’s plaques. This therapy is the first to demonstrate the capability to slow down the progression of Alzheimer's disease, marking a monumental step in its treatment.

Approved previously in countries including the United States, Japan, China, and various regions in Europe, Leqembi's market presence is expanding rapidly. The approval in Mexico addresses a significant public health concern, as approximately 1.3 million people are estimated to suffer from Alzheimer's disease in the country.

Clinical Research and Approval

The approval of Leqembi® is largely based on the substantial outcomes from the global Phase 3 Clarity AD clinical trial. This trial met all its primary and secondary endpoints with notable statistical significance, emphasizing the effectiveness of Leqembi in treating early Alzheimer's disease. The data garnered from this trial laid the groundwork for its subsequent approvals across several regions.

Collaboration Between BioArctic and Eisai

BioArctic and Eisai have been working together since 2005 to develop effective treatments for Alzheimer's. The collaboration has been fruitful, combining BioArctic’s research prowess with Eisai's clinical and commercial expertise. This partnership has led to the successful development of Leqembi, showcasing their commitment to addressing neurodegenerative diseases aggressively. BioArctic retains rights for joint commercialization of Leqembi in the Nordic region pending European approval, which demonstrates the strategic nature of their collaboration.

Looking Forward

As Eisai prepares to launch Leqembi in Mexico, healthcare providers anticipate offering this innovative treatment to patients, redefining the management of early Alzheimer's disease. The introduction of Leqembi could significantly alter the landscape for Alzheimer's care and patient outcomes, with expectations for continuous research to explore further applications and enhancements in treatment.

The approval of Leqembi in Mexico is a profound step not only for BioArctic and Eisai but also for millions grappling with Alzheimer’s and their families. It underscores a hopeful future where treatments may not only slow disease progression but also enhance the quality of life for many.

For more information, inquiries can be directed to Oskar Bosson at BioArctic via email or phone. As the healthcare community responds to this approval, the excitement surrounding Leqembi's potential continues to grow, reminding us that advances in medical research and collaboration hold the power to change lives significantly.