Eisai starts filing seeking approval for Alzheimer's drug lecanemab in China
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Eisai (OTCPK:ESALF) (OTCPK:ESALY) started submission of data for a biologics license application (BLA) seeking approval of China's National Medical Products Administration (NMPA) for the company and Biogen's (NASDAQ:BIIB) Alzheimer's drug lecanemab.
The Japanese drugmaker said the data submitted in this package includes data from a phase 2b trial (Study 201) in mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed AÎ² accumulation in the brain.
The filing also includes top-line data from a global phase 3 trial called Clarity AD. Eisai added that it will submit additional data including full data of the Clarity AD study, as directed by the NMPA.
In November it was reported that data showed lecanemab led to moderately less decline in cognition and function compared to placebo, but was also associated with higher rates of brain swelling and bleeding.
Lecanemab is currently under priority review in the U.S. with the FDA decision expected by Jan. 6, 2023.
Eisai added that it aims to file for traditional approval in the U.S. and for marketing authorization applications in Japan and the Europe by the end of the company's FY2022, which ends March 31, 2023.
Eisai is heading lecanemab's development and regulatory submissions globally, while both Eisai and Biogen will co-commercialize and co-promote the product with Eisai having final decision-making authority.
BioArctic (OTCPK:BRCTF) noted 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.