Cleveland Clinic, Mount Sinai not administering new Alzheimer’s drug
The Cleveland Clinic and the Mount Sinai Health System, two major health systems in the U.S., have decided they would not administer Biogen’s new Alzheimer’s drug following the Food and Drug Administration’s (FDA) controversial approval.
The Cleveland Clinic issued a statement saying its panel of experts decided against carrying the drug Aduhelm, also called aducanumab, after having “reviewed all available scientific evidence.” A spokesperson said individual physicians will be allowed to prescribe Aduhelm, but patients will need to go elsewhere to get it.
“Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,” the statement reads.
Mount Sinai also released a statement saying Aduhelm will not be given out within the health system until the inspector general for the Department of Health and Human Services finishes its investigation of the FDA approval.
“Depending on this outcome, if appropriate, our experts will follow formulary addition protocols and consider best practices for Aduhelm to inform clinical practice,” the statement said.
Background: The systems’ refusal to give out Aduhelm comes after the FDA approved the drug to treat Alzheimer’s last month, despite the agency’s advisory committee overwhelmingly recommending to reject authorization.
Following the criticism and Stat’s reporting, acting FDA Administrator Janet Woodcock requested a federal investigation into the agency’s authorization of Aduhelm last week.