Alzheimer’s Disease Antibody Treatment Awaits Final Approval
Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) had accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBI™, supporting the conversion of the accelerated approval of LEQEMBI to an FDA traditional approval.
The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.
As of March 6, 2023, the FDA plans to hold an Advisory Committee meeting to discuss this humanized immunoglobulin gamma 1 monoclonal antibody application but has not publicly announced the meeting date.
LEQEMBI was approved under accelerated approval in the U.S. and was on January 18, 2023.
This indication is approved under accelerated approval based on a reduction in amyloid beta plaques observed in patients treated with LEQEMBI.
The accelerated approval was based on data demonstrating that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining AD feature.
Treatment with LEQEMBI should be initiated in 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.
Continued approval for this indication may be contingent upon verification of clinical benefit.
The FDA has not approved any AD vaccine candidates as of March 6, 2023.