The Food and 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. and Biogen Inc., 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 percent compared with a placebo….