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FDA Approval of Lecanemab (Leqembi) for Alzheimer’s Disease Fails Patients and the Public

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) today gave full approval to the drug lecanemab (Leqembi) to treat adults with Alzheimer’s disease. In January  Public Citizen urged the agency not to approve the drug, and in June Public Citizen urged the agency not to grant full approval. Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, released the following statement.

“Although expected, the FDA’s decision to grant full approval for lecanemab to treat adult patients with Alzheimer’s disease is misguided and very disappointing. The evidence for the drug’s clinical benefits does not outweigh its substantial health risks. The fact that a black box warning for brain swelling and bleeding risks has been added to the prescribing information for lecanemab underscores the substantial safety concerns. Patients with Alzheimer’s disease and their families are understandably desperate for better treatments. When it approves drugs for Alzheimer’s disease with little or no benefit and significant health risks, the FDA fails patients and the public.”