Eisai files for approval of Alzheimer's drug lecanemab in EU
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Eisai (OTCPK:ESALY) (OTCPK:ESALF) submitted an application to the European Medicines Agency (EMA) seeking approval of Alzheimer's disease (AD) drug lecanemab.
The Japanese company filed a marketing authorization application (MAA) for lecanemab to treat early Alzheimer's disease (mild cognitive impairment due to AD and mild AD dementia).
Last week, the the U.S. Food and Drug Administration (FDA) had granted accelerated approval to Eisai and Biogen's (NASDAQ:BIIB) lecanemab, to be sold as Leqembi, to treat AD.
Eisai said the MAA was backed by data a phase 3 trial called Clarity AD and a phase 2b study, dubbed Study 201.
Eisai added that it started filing data to the Chinese drug regulator for lecanemab in December 2022 and in Japan it plans to submit an application by March 31, 2023.
Eisai noted that it serves as the lead for lecanemab development and regulatory submissions globally, but both the company and Biogen are co-commercializing and co-promoting the product. Eisai has the final decision-making authority.
Meanwhile, BioArctic (OTCPK:BRCTF) said that in conjunction with the regulatory filing to the EMA, and if accepted by the agency, the company is entitled to a milestone of â¬5M.
BioArctic added that it has a right to commercialize lecanemab in the Nordic under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai.