Eisai Co., Ltd. and Biogen Inc. have made an announcement regarding the approval from Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) for their humanized anti-soluble aggregated amyloid-beta (Aß) monoclonal antibody, “Leqembi” (lecanemab), designed for early Alzheimer’s disease (AD) therapy.
Leqembi has been shown to selectively target both soluble and insoluble Aß aggregates (protofibrils and fibrils, respectively), which are crucial components of Aß plaques, thus reducing both protofibrils and plaques in the brain. Remarkably, it stands as the inaugural approved treatment that shows the potential to lessen disease advancement and decelerate cognitive and functional falloff via this method. Besides Mexico, Leqembi is also approved and available in countries like the US, Japan, China, South Korea, Hong Kong, Israel, the UAE, and the UK.
This approval roots from the extensive global phase 3 Clarity AD study, in which Leqembi succeeded in achieving its primary and key secondary objectives with significant statistical results.
In Mexico, an estimated 1.3 million individuals suffer from AD, representing 60-70% of all dementia cases, with the majority being over 65.
Eisai leads the development and manages the global regulatory submissions of Leqembi, partnering with Biogen for co-commercialization and co-promotion, while maintaining the decisive authority. This partnership extends to the marketing of Leqembi in Mexico.
Lecanemab emerges from a strategic research partnership with BioArctic and is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, aimed at both soluble and insoluble amyloid-beta (Aß) aggregates.
Globally, lecanemab is approved and available in major markets for early Alzheimer’s stages (MCI or mild dementia) thanks to Phase 3 data from Eisai’s Clarity AD trials, showcasing meaningful outcomes in primary and secondary measures. Several countries continue to review the drug for potential approval, with a positive nod from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in November 2024.
Eisai and Biogen’s developmental collaboration dates back to 2014, with Eisai holding the lead on lecanemab’s global clinical foundation and final commercial decisions, while both companies partner in global commercialization pursuits. Since 2005, Eisai and BioArctic have partnered for long-term AD treatment enhancements, with Eisai acquiring worldwide rights to develop and sell lecanemab in 2007, and further agreements achieved in May 2015.
Eisai’s guiding principle is to prioritize patient welfare and the broader community, focusing on enhancing health benefits and reducing inequities as part of their human healthcare (hhc) mission.
Biogen, since its inception in 1978, has been a frontrunner in biotechnology, creating groundbreaking treatments to improve patient outcomes and generating value for stakeholders and communities alike.