Biogen, Eisai Alzheimer’s Drug Wins FDA Approval

Eisai and Biogen have announced that the FDA has approved lecanemab-irmb (brand-named Leqembi in the U.S.) for the treatment of Alzheimer’s disease (AD) under the Accelerated Approval Pathway. The approval is based on Phase 2 data that demonstrated that Leqembi reduced the accumulation of amyloid beta (Aβ) plaque in the brain, a defining feature of AD. Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ). Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
Treatment with Leqembi is indicated for patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Leqembi. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

“The approval of LEQEMBI provides new hope to patients with Alzheimer’s disease. Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors. Our focus now is on the path forward, working alongside Eisai with the goal of making Leqembi available to patients who may benefit from this treatment as soon as possible,” said Christopher A. Viehbacher, Biogen President and CEO. (Source: Biogen Website, 06 January, 2023)