Eisai Seeks Traditional Approval With New Lecanemab Data Under FDA Review

The Food and Drug Administration has agreed upon establishing traditional approval of lecanemab-irmb (Leqembi™) for the treatment of Alzheimer disease.

The Food and Drug Administration (FDA) has accepted to priority review the supplemental Biologics License Application (sBLA) for lecanemab-irmb (Leqembi) to convert its accelerated approval status to a traditional approval for the treatment of Alzheimer disease.

Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. It reduces amyloid beta plaques in the brain, which is a defining pathophysiological feature of Alzheimer disease.

Lecanemab received accelerated approval in January 2023 based on data from a phase 2b trial (ClinicalTrials.gov Identifier: NCT01767311). The study showed that treatment with lecanemab resulted in a statistically significant reduction in brain amyloid plaque compared with placebo.

The sBLA is supported by data from the confirmatory, double-blind, placebo-controlled phase 3 Clarity AD trial (ClinicalTrials.gov Identifier: NCT03887455), which included 1795 patients with early Alzheimer disease. Patients were randomly assigned 1:1 to receive either lecanemab 10mg/kg via intravenous infusion once every 2 weeks or placebo. The primary endpoint was the change from baseline to 18 months in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score.

Findings demonstrated a statistically significant treatment difference in the CDR-SB score change (-0.45; [95% CI, -0.67, -0.23]; P <.001), indicating a reduction in clinical decline of 27% with lecanemab compared with placebo. Highly statistically significant changes in CDR-SB were observed as early as 6 months.

Results also showed statistically significant improvements in all key secondary endpoints compared with placebo (P <.001), including changes in amyloid levels in the brain (as measured by amyloid positron emission tomography), the AD Assessment Scale-Cognitive Subscale 14 (-1.44 [95% CI, -2.27, -0.61]), the AD Composite Score (-0.050 [95% CI, -0.074, -0.027), and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (2.0 [95% CI, 1.2-2.8]).

A Prescription Drug User Fee Act target date of July 6, 2023 has been set for the application.

This article originally appeared on MPR


    1. FDA accepts Eisai’s filing of a supplemental Biologics License Application and grants Priority Review for traditional approval of Leqembi™ (lecanemab-irmb) for the treatment of Alzheimer’s disease. News release. Eisai. Accessed March 5, 2023. https://www.prnewswire.com/news-releases/fda-accepts-eisais-filing-of-a-supplemental-biologics-license-application-and-grants-priority-review-for-traditional-approval-of-leqembi-lecanemab-irmb-for-the-treatment-of-alzheimers-disease-301762846.html.

    1. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. Published online January 5, 2023. doi:10.1056/NEJMoa2212948