An FDA advisory panel has unanimously recommended granting full approval to Leqembi, a new type of Alzheimer’s drug that modestly slows cognitive decline in patients in the early stages of the disease. The panel voted 6-0 in favor of Leqembi, which treats people with early-stage Alzheimer’s and mild cognitive impairment by targeting sticky plaques of protein called amyloid in the brain. The only other anti-amyloid drug on the market, Aduhelm, was approved last year despite objections from the FDA’s advisory panel over a lack of evidence that it works. Leqembi was given accelerated approval in January but still needs final approval from the FDA, which is set to decide by July 6. Critics have expressed concerns over the drug’s minimal benefits, serious safety concerns, and high cost. Medicare currently only covers Leqembi for patients enrolled in a clinical trial, and the agency’s decision is crucial for its further coverage.
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