Biogen, Eisai's Alzheimer's therapy lecanemab gets priority review in China
MediaProduction

China's National Medical Products Administration (NMPA) granted priority review to Biogen (NASDAQ:BIIB) and Eisai's (OTCPK:ESALF) application seeking approval of Alzheimer's disease (AD) therapy lecanemab.
Priority review is expected to provide for a shortened review period.
The Japanese drugmaker had started filing data for the biologics license application (BLA) to the NMPA in December 2022.
The BLA included data from a phase 2 trial (Study 201) and data from a phase 3 trial, dubbed Clarity AD, in mild cognitive impairment (MCI) due to AD and mild AD (collectively known as early AD) with confirmed AÎ² accumulation in the brain.
Eisai noted that it will submit additional data including full data from the Clarity AD trial, as told by the NMPA.
At the start of this year, 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 Japan.
Eisai serves as the lead of lecanemab development and regulatory filings globally with both Eisai and Biogen co-commercializing and co-promoting the drug, according to the company.
BioArctic (OTCPK:BRCTF) has a right to commercialize lecanemab in the Nordic under certain conditions.