Eisai Co. Ltd. and Biogen Inc. announced on Monday that the United States Food and Drug Administration (FDA) accepted their application to convert the accelerated to a traditional approval of Leqembi (lecanemab) treatment for Alzheimer's disease.
In January, the drug was authorized under an expedited procedure which is used as a path to greenlight drugs for serious conditions where there is an unmet medical need.
Leqembi is used in patients with mild cognitive impairment or mild dementia stage of the disease, and the latest application is based upon the completed Phase 3 clinical trial.
