Eisai’s sBLA Accepted for Traditional Approval of LEQEMBI for Alzheimer’s

Eisai and Biogen announced that the U.S. FDA has accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMB (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to traditional approval.

The LEQEMBI 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. 

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils) 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.

On the same day that LEQEMBI received accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.

The sBLA is based on the findings from Eisai’s recent global confirmatory Phase 3 trial, Clarity AD. LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results.

LEQEMBI was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023.

The accelerated approval was based on Phase 2b data that demonstrated LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI’s clinical benefit in a confirmatory trial.

Meanwhile, the FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.