Eisai submits sBLA to FDA for traditional approval of LEQEMBI in Alzheimer’s

Eisai and Biogen announced Eisai has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration supporting the conversion of the Accelerated Approval of LEQEMBI 100 mg/mL injection for intravenous use to a traditional approval. This sBLA is subject to validation of whether the FDA accepts the application for review. LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta, approved under Accelerated Approval Pathway by the FDA on January 6, 2023, 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 Abeta pathology. Accelerated Approval of LEQEMBI was based on Phase 2 data that demonstrated LEQEMBI reduced the accumulation of Abeta plaque in the brain, a defining feature of AD. Continued approval for this indication is contingent upon verification of LEQEMBI’s clinical benefit in a confirmatory trial. The sBLA for LEQEMBI is based on the data from the Phase 3 confirmatory Clarity AD clinical trial. In Clarity AD, LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results, and the profile of Amyloid-Related Imaging Abnormalities incidence was within expectations. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journals. Eisai has initiated submission of data for BLA to the National Medical Products Administration 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 FY2022, 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.