Eisai has submitted a supplemental biologics license application to the U.S. Food and Drug Administration for traditional approval of leqembi (lecanemab-irmb) for the treatment of alzheimer's disease, Eisai Co., Ltd. and Biogen Inc. (BIIB) said in a statement on Friday. The submission for traditional approval follows FDA accelerated approval of leqembi on the same day.
Earlier today, the FDA approved Eisai Co., Ltd. and Biogen Inc.'s Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer's disease.
Treatment with leqembi should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aß pathology.
Eisai said it has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. Eisai plans to file for marketing authorization applications of lecanemab in Japan and EU by the end of Eisai's fiscal year 2022, which ends March 31, 2023.
Eisai serves as the lead of leqembi 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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