LEQEMBI? (Lecanemab) Approved for Early Alzheimer’s Treatment in Mexico

Eisai Co., Ltd. and Biogen Inc. have announced a major milestone in the treatment of Alzheimer’s disease. The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has officially approved LEQEMBI? (lecanemab) for the treatment of early Alzheimer’s disease (AD). This innovative therapy represents a significant advancement in the fight against this debilitating condition.

About LEQEMBI?

LEQEMBI? (lecanemab-irmb) HCP is a humanized monoclonal antibody that targets soluble aggregated amyloid-beta (Aβ) protofibrils and insoluble Aβ aggregates (fibrils) — major contributors to the formation of Aβ plaques in the brain. By reducing both Aβ protofibrils and plaques, LEQEMBI slows cognitive and functional decline, offering new hope for patients and their families. It is the first approved treatment shown to reduce the rate of disease progression through this mechanism.

LEQEMBI has already gained approval in multiple countries, including the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain, and is now poised to make a significant impact in Mexico.

Clinical Evidence

The approval of LEQEMBI in Mexico is based on robust findings from the global Phase III Clarity AD study. This pivotal trial demonstrated that LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. These findings underline its effectiveness in slowing the progression of Alzheimer’s disease.

Impact in Mexico

Alzheimer’s disease is a growing public health challenge in Mexico, with an estimated 1.3 million people affected. AD accounts for 60-70% of all dementia diagnoses, most commonly impacting individuals over the age of 65. The approval of LEQEMBI brings a groundbreaking treatment option to patients in Mexico, addressing a critical need.

Global and Local Collaboration

Eisai leads the global development and regulatory submissions for LEQEMBI, while Eisai and Biogen collaborate to co-commercialize and co-promote the therapy. In Mexico, the two companies will work closely to ensure that LEQEMBI reaches patients who can benefit most from this innovative treatment.

Looking Ahead

With the approval of LEQEMBI in Mexico, Eisai and Biogen continue to advance their shared mission of delivering innovative solutions to the Alzheimer’s community worldwide. This marks another step forward in transforming the lives of patients and caregivers affected by this devastating disease.