Biogen/Eisai Alzheimer Drug Wins Favorable Vote from FDA Advisory Committee

Biogen and partner Eisai have announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease (AD). Additionally, the committee members confirmed the overall benefit-risk profile of Leqembi, the clinical meaningfulness of the data and discussed its use in specific subgroups of patients.

Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against soluble and insoluble forms of amyloid beta (Aβ), received accelerated approval on January 6, 2023, and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that Leqembi reduced the accumulation of Aβ plaque in the brain, a defining feature of Alzheimer’s disease. The action date for the traditional FDA approval is July 6, 2023.

The unanimous decision by the panel of independent experts was based on the supplementary Biologics License Application (sBLA) which includes data from Eisai’s large global confirmatory Phase 3 Clarity AD trial. The Clarity AD trial met its prespecified primary endpoint, demonstrating a highly statistically significant slowing of cognitive and functional decline compared to placebo over 18 months. Highly statistically significant treatment effects were also observed for all secondary endpoints that examined cognition and functional changes using other validated scales.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. (Source: Biogen Website, 09 June, 2023)