Eisai and Biogen’s drug Leqembi, aimed at treating Alzheimer’s, has received unanimous support from a panel of independent advisors to the Food and Drug Administration (FDA), indicating full approval is expected this summer. The advisors voted 6-0 in success of Eisai’s data, which showed a substantial clinical benefit for patients. While the FDA is not obliged to adhere to the advisory committee’s recommendation, their opinions carry significant weight in the final decision. Eisai has priced Leqembi at $26,500 per year, rendering it financially impossible for most patients without Medicare coverage. The decision will determine whether Medicare comprehensively covers the treatment, with a final decision due on July 6. Leqembi is administered twice monthly via intravenous infusion, and targets the amyloid protein, referred to as plaque, which is linked with the disease. The FDA has identified serious risks of brain swelling and bleeding as possible side effects. While Leqembi is now available on the US market after receiving fast-track approval in January, very few patients can access it because Medicare coverage is restricted to individuals in clinical trials.
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