Eisai and Biogen Inc. have announced that Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) has approved LEQEMBI (lecanemab), a humanized monoclonal antibody, for the treatment of early Alzheimer’s disease (AD). This approval marks an important step in providing new hope for individuals affected by this progressive and debilitating condition.
Mechanism of Action
LEQEMBI is designed to target and bind selectively to soluble amyloid-beta (Aβ) aggregates, known as protofibrils, and insoluble Aβ aggregates, commonly referred to as fibrils. These aggregates are key components of amyloid plaques in the brain, which are strongly linked to the progression of Alzheimer’s disease. By reducing both protofibrils and plaques, LEQEMBI slows cognitive and functional decline, making it the first approved treatment in its class to demonstrate a significant reduction in disease progression.
This innovative approach builds on the understanding that protofibrils are highly toxic forms of Aβ. They are believed to play a central role in the cognitive decline associated with Alzheimer’s by damaging neurons and disrupting the connections between brain cells. Reducing protofibrils is thought to protect neurons, thereby slowing disease progression and preserving cognitive function.
Basis for Approval
The approval of LEQEMBI in Mexico is based on robust data from the global Phase 3 Clarity AD study, a landmark trial that demonstrated statistically significant results in meeting its primary and all key secondary endpoints. These findings underscore LEQEMBI’s ability to effectively address early stages of Alzheimer’s, such as mild cognitive impairment due to AD or mild AD dementia.
LEQEMBI has already received approval in several other regions, including the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain. This widespread recognition reflects its efficacy and the global need for effective Alzheimer’s treatments.
The Impact of Alzheimer’s Disease in Mexico
Alzheimer’s disease is a major public health challenge in Mexico, affecting an estimated 1.3 million people, which accounts for 60-70% of all dementia diagnoses in the country. The condition predominantly impacts individuals over the age of 65, making it a critical concern as Mexico’s aging population continues to grow. The approval of LEQEMBI offers a much-needed option for patients and caregivers dealing with the immense physical, emotional, and economic burdens of the disease.
Collaborative Development and Commercialization
Eisai has led the global development and regulatory submissions for LEQEMBI, working closely with Biogen as a co-commercialization and co-promotion partner. In Mexico, the two companies will continue this collaboration to ensure the product’s availability and accessibility. Eisai retains final decision-making authority for LEQEMBI’s development and commercialization worldwide.
Addressing a Critical Need
LEQEMBI’s approval aligns with the growing recognition of Alzheimer’s disease as an urgent global health issue. The treatment’s novel mechanism of action—targeting the toxic protofibrils—offers a promising strategy to address the underlying biology of Alzheimer’s, rather than just managing its symptoms.
Protofibrils are not only implicated in plaque formation but are also directly harmful to neurons, causing damage to cell membranes and disrupting synaptic communication. By reducing protofibrils, LEQEMBI may prevent further neuronal injury and preserve cognitive functions. This approach represents a shift toward disease-modifying therapies, which aim to alter the course of Alzheimer’s rather than merely delaying its symptoms.
