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Three FDA advisers quit over agency approval of aduhelm

Three members of a U.S. Food and Drug Administration advisory committee have resigned after the agency this week approved a new drug for Alzheimer disease despi

medicalxpress.com

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Three members of a U.S. Food and Drug Administration advisory committee have resigned after the agency this week approved a new drug for Alzheimer disease despite a lack of strong proof that it provides any benefits to patients.

Aduhelm (aducanumab)—a monthly infusion priced at $56,000 per year—is the first treatment for Alzheimer disease approved by the FDA in 18 years, and its approval was pushed by patient advocacy groups because there are only five other treatments available, The New York Times reported. Drug maker Biogen plans to begin distributing the drug in about two weeks and expects more than 900 sites nationwide to soon be ready to administer it.