US FDA advisers to weigh full approval for Eisai-Biogen's Alzheimer's drug
Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer's drug developed by Eisai Co Ltd 4523.T and Biogen Inc BIIB.O, according to a federal filing on Monday.
The drug, Leqembi was granted accelerated approval by the FDA in January for patients in the earliest stages of the mind-wasting disease.
The U.S. health regulator grants the so-called accelerated approval based on data that show therapies are likely to work, and requires confirmatory trials later to give them full approval.
In the large trial of Leqembi, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer's by 27% compared with a placebo.
The FDA's independent advisers, who are scheduled to meet on June 9, will discuss the data from the study.
Leqembi belongs to a class of treatments that aim to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.
April 10, 2023