Biogen, Eisai's Alzheimer's drug lecanemab gets review in EU
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The European Medicines Agency (EMA) accepted to review Biogen (NASDAQ:BIIB) and Eisai's (OTCPK:ESALY) (OTCPK:ESALF) Alzheimer's disease (AD) therapy lecanemab.
Earlier in January, the Japanese company had filed a marketing authorization application (MAA) for lecanemab to treat early AD (mild cognitive impairment due to AD and mild AD dementia) with confirmed amyloid pathology.

In the first week of January, the the U.S. Food and Drug Administration (FDA) had granted accelerated approval to lecanemab, which would be sold as Leqembi, to treat AD.
Eisai's MAA was backed by data from a phase 3 trial called Clarity AD and a phase 2b study, dubbed Study 201.
Eisai has also filed for approval of the drug in Japan and started initiated submission of data for an application in China.
Meanwhile, BioArctic (OTCPK:BRCTF) said that in conjunction with the EMA's acceptance of the regulatory filing 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.
SA Contributor Analysis: Eisai And Biogen's Lecanemab: A Flawed Treatment For Alzheimer's Disease