A panel of expert advisers on Friday unanimously agreed that a late-stage trial of Eisai and Biogen's Alzheimer's drug Leqembi verified the benefit of the treatment for those at an early stage of the disease, clearing the way for traditional U.S. approval.
All six advisers on the panel voted in favor of Leqembi for treatment of the mind-wasting illness.
Regular approval by Food and Drug Administration is expected to expand Medicare payment for the treatment. It would also make Leqembi the first in its class of drugs that work by removing sticky amyloid plaques from the brain to achieve the regulatory milestone.