The US Food and Drug Administration (FDA) has given the green light to review an indication extension filing for Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy developed by Japanese pharmaceutical company Eisai Co., Ltd. (TYO: 4523). Currently, Leqembi has conditional approval in Japan as a bi-weekly treatment for Alzheimer’s disease (AD) patients exhibiting mild cognitive impairment or are in the mild dementia stage of the disease. The new filing seeks to expand its use as a once-monthly maintenance therapy for early-stage AD.
Eisai’s submission is bolstered by modeled data from Phase II and III clinical trials, along with their open-label extension studies, which demonstrate a significant reduction in amyloid-beta plaques, a hallmark of Alzheimer’s disease. The drug, which is administered intravenously, is already approved in China and Japan, and is under regulatory review in several other global markets.- Flcube.com
