STOCKHOLM - The European Medicines Agency's (EMA) Scientific Advisory Group (SAG) is set to review the Marketing Authorisation Application (MAA) for the Alzheimer's treatment lecanemab, known by the brand name Leqembi®, developed by BioArctic AB's partner Eisai. The SAG meeting is scheduled within the first quarter of 2024, following a standard procedure for new medicinal products.
Eisai, leading the development and regulatory filings for Leqembi®, anticipates the European Commission's decision on the MAA by the second quarter of 2024, provided the Committee for Medicinal Products for Human Use (CHMP) opinion is favorable by March 31, 2024. The SAG, an independent body, offers scientific advice to the CHMP on products under review.
BioArctic, based in Sweden, has rights to commercialize lecanemab in the Nordic region pending European approval. The company, along with Eisai, is preparing for joint commercialization in these markets. Lecanemab is an amyloid beta-directed antibody, indicated as a disease-modifying treatment for Alzheimer's disease. It is already approved in the United States, Japan, and China for treating mild cognitive impairment and mild dementia stages of Alzheimer's.
The drug's development stems from a strategic alliance between BioArctic and Eisai. Lecanemab targets aggregated soluble and insoluble forms of amyloid-beta, a characteristic of Alzheimer's disease. In addition to the EU, Eisai has submitted applications for lecanemab's approval in various other countries, with some like Israel and Great Britain granting it priority review or innovative licensing pathways.
BioArctic's collaboration with Eisai began in 2005, focusing on Alzheimer's treatments. The partnership includes agreements on the development and commercialization of lecanemab, with BioArctic entitled to regulatory, commercialization, and sales milestone payments as well as royalties on global sales.
This news is based on a press release statement. BioArctic AB is a biopharma company specializing in neurodegenerative diseases, with lecanemab being its flagship product, developed in partnership with Eisai, which holds the global commercialization rights.
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