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In a vote on Friday, the six advisers unanimously voted to recommend the traditional approval of Leqembi, a treatment made by Biogen and partner Eisai (TYO:4523) that is designed to slow the progression of the mind-wasting disease.
The Food and Drug Administration is now expected to grant regular approval to the medicine by July 6, making it the first disease-modifying drug to reach this milestone. Current treatments can help to address certain symptoms of the disease, but have yet to be able to alter its course.
Analysts at SVB Securities said that there were few surprises in the advisory panel’s discussion. Briefing documents released prior to the decision suggested that safety worries would most likely not hurt the chances that the drug would be given the green light by regulators.
The SVB Securities analysts noted that the advisers were largely concerned with mitigating risks the drug could present to certain patients suffering from Alzheimer’s.
Leqembi, which aims to remove sticky amyloid plaques from the brain, was previously granted accelerated approval by the FDA in January. This allowed Leqembi to be used to treat serious cases of Alzheimer’s ahead of the release of figures from a conclusive clinical trial.
Analysts quoted by Reuters believe that, once given traditional approval, Leqembi sales could rise to as high as $5.7 billion by 2030.
