Lecanemab, marketed as Leqembi, is a monoclonal antibody targeting amyloid-beta in Alzheimer's patients. It is part of a strategic alliance between Eisai and BioArctic and is under review in 17 countries. The U.S. FDA recently approved a supplemental application for maintenance dosing, and a subcutaneous injection formulation is being developed for patient convenience. Eisai leads the global development and regulatory submissions, with both companies co-commercializing the product. The collaboration between Eisai and Biogen began in 2014, focusing on Alzheimer's treatments.
Key takeaways:
- Eisai and Biogen announced an update on the regulatory review of lecanemab for early Alzheimer's disease in the European Union.
- The European Commission has requested the CHMP to consider new safety information and risk minimization measures for lecanemab.
- Lecanemab has been approved in multiple countries, including the U.S., Japan, and the UK, and is under review in 17 other countries.
- Eisai and Biogen have been collaborating on Alzheimer's disease treatments since 2014, with Eisai leading the development and regulatory submissions globally.