BRIEF—Mexican approval for Alzheimer’s drug Leqembi

The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for the treatment of early Alzheimer’s disease (AD).

Japan’s Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and US biotech Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Eisai and Biogen will co-commercialize and co-promote Leqembi in Mexico.

Around 1.3 million people in Mexico are estimated to suffer from AD, accounting for 60%-70% of all dementia diagnoses. AD most commonly affects individuals over the age of 65.