Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to a validation to determine whether the EMA accepts the application for review.
The Clarity AD study met its primary endpoint (CDR-SB(1): Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.
In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journals.
In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In China, Eisai has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai’s fiscal year 2022, which ends March 31, 2023.
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.
(1) CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.
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