Biogen, Eisai's Alzheimer's drug lecanemab gets priority review in Japan
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The Japanese Ministry of Health, Labour and Welfare (MHLW) granted priority review to Biogen (NASDAQ:BIIB) and Eisai's (OTCPK:ESALY) (OTCPK:ESALF) application seeking approval of Alzheimer's disease (AD) therapy lecanemab.
Priority review provides for a shortened review period.
Earlier in January, Eisai had filed an application to the Pharmaceuticals and Medical Devices Agency (PMDA) to treat early AD (mild cognitive impairment due to AD and mild AD dementia) with confirmed presence of amyloid pathology in the brain.

The application was backed by data from a phase 3 trial called Clarity AD and a phase 2b study, dubbed Study 201.
In the first week of January, the the U.S. Food and Drug Administration (FDA) granted accelerated approval to lecanemab, which would be sold as Leqembi, to treat AD.
Lecanemab is also under review in the EU and Eisai has already started submission of data for an application in China.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product.
BioArctic (OTCPK:BRCTF) has a right to commercialize lecanemab in the Nordic under certain conditions.