#Mexico #Mexico City #Leqembi #BioArctic #Alzheimer’s

Leqembi® Approved in Mexico for Treating Early Alzheimer's Disease

In a significant development for Alzheimer's treatment, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has granted approval for Leqembi (lecanemab), a groundbreaking therapy designed to combat early Alzheimer's disease. This decision, announced by BioArctic's partner Eisai, comes in response to the pressing health crisis posed by Alzheimer's, which affects an estimated 1.3 million individuals in Mexico alone.

What is Leqembi?

Leqembi is a humanized immunoglobulin gamma 1 monoclonal antibody that specifically targets aggregations of amyloid-beta, a hallmark of Alzheimer's pathology. The treatment works by binding to both soluble protofibrils and insoluble fibrils, which are major components of amyloid plaques in the brains of those suffering from the disease. Through this mechanism, Leqembi aims to reduce the presence of these harmful aggregates, thereby slowing the progression of the disease and mitigating cognitive decline.

Clinical Background and Approval Process

The approval of Leqembi stems from comprehensive data derived from the global Phase 3 Clarity AD trial, where it demonstrated statistically significant results across its primary and secondary endpoints. The trial confirmed the drug’s effectiveness in slowing down the cognitive and functional decline that characterizes early Alzheimer's disease. Other countries, including the United States, Japan, South Korea, and several European nations, have already recognized Leqembi as a viable treatment option, which underscores its potential at a global scale.

A Collaborative Journey

The journey of Leqembi is rooted in a long-term collaboration between BioArctic and Eisai, initiated in 2005. BioArctic scientists, based on the groundbreaking work of Professor Lars Lannfelt who discovered the Arctic mutation linked to Alzheimer's disease, first developed lecanemab. Since then, Eisai has taken the lead in clinical development and market approval processes. Furthermore, BioArctic retains rights for joint commercialization in the Nordic region, pending European regulations.

The Impact of Approval

The approval of Leqembi in Mexico signals hope for many affected families and individuals grappling with Alzheimer’s disease. With its ability to target the very mechanisms believed to drive the progression of the disease, Leqembi presents a new pathway for treatment that could enhance quality of life for patients at early stages.

Ongoing Research and Future Prospects

Beyond its recent approval, research and clinical trials continue to evaluate the effectiveness of lecanemab. Eisai is looking to expand its regulatory approvals globally, with applications submitted for 16 additional regions, including the European Union. Additionally, ongoing studies like the AHEAD 3-45 trial explore the effects of lecanemab in preclinical Alzheimer's patients, indicating a commitment to understanding and addressing Alzheimer's from multiple angles.

BioArctic remains at the forefront, leveraging its innovative BrainTransporter™ technology in future research endeavors, which aims to enhance the delivery of therapeutic antibodies across the blood-brain barrier, potentially improving treatment efficacy.

Conclusion

Leqembi's recent approval in Mexico is a landmark achievement in the fight against Alzheimer's disease. As the healthcare community continues to strive for effective solutions, treatments like Leqembi stand out for their scientific foundation and clinical promise. Patients, caregivers, and researchers all await the next steps in making such groundbreaking treatments accessible to those in need.