Expected FDA approval would make Leqembi the first in its class of drugs that work by removing sticky amyloid plaques from the brain to achieve the regulatory milestone.
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.Regular approval by Food and Drug Administration - a decision expected by July 6 - is likely to expand Medicare payment for the treatment.
"I believe the benefit versus risk are beneficial, acceptable and in line with this class of therapeutics, especially considering the burden of the disease and the progressive nature of the disease," said panel member Dr. Tanya Simuni, professor of neurology at Northwestern University Feinberg School of Medicine.
Members of the panel generally said the risks for those with two copies of the APOE4 gene were balanced by the drug's benefits, although they urged the FDA to strengthen language in the drug's prescribing label recommending genetic testing for the risk gene. Under accelerated approval, Medicare restricted payment of the drug to those in a clinical trial, but no such trials are underway for Leqembi, resulting in negligible sales. Most U.S. Alzheimer's patients are Medicare-eligible.participate in a health agency databaseWall Street analysts widely expect the FDA to grant traditional approval for the drug. Analysts have forecast Leqembi sales topping $1 billion in 2026 and reaching $5.7 billion by 2030.
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