Eisai Co., Ltd. and Biogen Inc. (BIIB) said that an application for manufacturing and marketing approval for an anti-amyloid-ß (Aß) protofibril antibody, lecanemab (generic name, U.S. brand name: LEQEMBI), in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare.
Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.
According to the companies, Lecanemab selectively binds and eliminates soluble, toxic Aß aggregates (protofibrils) that are thought to contribute to the neurotoxicity in Alzheimer's disease. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application to the FDA for approval under the traditional pathway.
In Europe, Eisai submitted a marketing authorization application to the European Medicines Agency on January 9, 2023 and accepted on January 26, 2023.
In China, Eisai initiated submission of data for a Biologics License Application to the National Medical Products Administration in December 2022.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
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