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FDA Fails Patients By Approving Flawed Alzheimer’s Disease Drug Donanemab (Kisunla)

WASHINGTON, D.C. – The Food and Drug Administration (FDA) on Tuesday approved donanemab-azbt (Kisunla) for the treatment of Alzheimer’s disease. The drug is an amyloid beta-directed antibody that is administered as an intravenous infusion every four weeks. In recent testimonybefore an FDA advisory committee and in a press statement, Public Citizen urged the agency not to approve donanemab. Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, released the following statement:

“Although expected, the FDA’s approval of donanemab is very disappointing and fails patients with Alzheimer’s disease and their families. The evidence that donanemab slows the speed of progression of Alzheimer’s disease as compared to placebo is very modest. The drug has substantial safety risks, including brain swelling and bleeding, that outweigh these purported benefits. The prescribing information includes a boxed warning, the strongest warning the FDA requires, about these serious risks and cautions clinicians to “consider the benefit for the treatment of Alzheimer’s disease and risk” when deciding whether to treat with the drug. Donanemab should not have been approved.”