Eisai submits sBLA to the FDA for traditional approval of Leqembi for the treatment of Alzheimer’s disease.

This sBLA is subject to validation of whether the FDA accepts the application for review. Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibrils”- large Abeta aggregated soluble species of 75-500 Kd) and insoluble forms of amyloid beta (Abeta), approved under Accelerated Approval Pathway by the FDA on January 6, 2023, for the treatment of Alzheimer’s Disease (AD). 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 II 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 III 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 (ARIA) 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 (CTAD) conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journal ( previously cited)

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