FDA Accepts sBLA for Traditional Approval of LEQEMBI for Alzheimer's Disease Treatment

The U.S. Food and Drug Administration (FDA) has accepted Eisai's supplemental Biologics License Application (sBLA) for LEQEMBI™ (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. This application is based on the confirmatory Phase 3 Clarity AD data and has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application.

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ), approved under the Accelerated Approval Pathway for the treatment of Alzheimer's Disease (AD) on January 6, 2023. It is indicated for patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.

The sBLA submission is based on findings from Eisai’s large, global confirmatory Phase 3 clinical trial, Clarity AD, where LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results. The results were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference and published in the New England Journal of Medicine.

LEQEMBI was launched in the U.S. on January 18, 2023, following its accelerated approval based on Phase 2b data demonstrating reduced accumulation of Aβ plaque in the brain. The FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

Eisai leads the development and regulatory submissions for lecanemab globally, with both Eisai and Biogen co-commercializing and co-promoting the product. BioArctic has the right to commercialize lecanemab in the Nordic under certain conditions and is preparing for commercialization in the Nordics together with Eisai.

Important safety information includes warnings about amyloid related imaging abnormalities (ARIA), which can cause brain edema or microhemorrhage. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. LEQEMBI can also cause infusion-related reactions, which were observed in 20% of LEQEMBI-treated patients in Study 1.

For further information, please contact Oskar Bosson, VP Communications and IR at BioArctic.