The Cleveland Clinic said it will not carry Biogen’s controversial Alzheimer’s drug after a panel of experts “reviewed all available scientific evidence on this medication.” The clinic, one of the largest medical centers in the country, did say that individual physicians can prescribe Aducanumab, marketed as Aduhelm, to appropriate patients, but that they would then have to receive the infusion at an outside facility.
“Based on current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,” a Cleveland Clinic statement provided to Fox News said. “However, we support continued research in this area, and when additional data become available we will re-evaluate this medication for use in our patients.”
The decision follows a letter posted by the FDA chief asking for an investigation into staff communications with Biogen during the approval process.
“There continue to be concerns raised, however, regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process,” Dr. Janet Woodcock, acting FDA commissioner, said in a letter posted online last Friday. “To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures.”
Mount Sinai Health System in New York has also decided not to carry Aduhelm.
“The FDA’s approval of Aduhelm has raised serious concerns and questions by clinicians, patients, and caregivers and a cautious approach is required,” the health system said, in a statement provided to Fox News. “Mount Sinai Health System will not administer Aduhelm until the outcome of the FDA Inspector General’s Investigation of Biogen is complete. Depending on this outcome, if appropriate, our experts will follow formulary addition protocols and consider best practices for Aduhelm to inform clinical practice.”
The FDA moved to grant the drug Accelerated Approval status in June, which allows for drugs targeting serious conditions that fill an unmet medical need to be approved “based on a surrogate endpoint.”
The FDA’s decision was met with mixed reviews and saw several members of an expert advisory panel resign in its wake. The drug’s approval stems from data collected during two Phase 3 clinical trials, but only one study met a primary endpoint while the other did not. The Peripheral and Central Nervous System Drugs Advisory Committee had advised in November 2020 that it was not reasonable to consider clinical benefit of the drug based on one successful study.
Still, the agency moved forward with its decision, prompting many in the medical community to voice concern about whether the drug would be beneficial to patients. Earlier this month, the FDA then moved to limit the use of the drug in an attempt to clear up confusion over who should be prescribed the drug.
The new label emphasizes that it Aduhelm should be prescribed for patients with early or mild Alzheimer’s. It has not been studied in patients with advanced forms of the disease.
Aduhelm marked the first Alzheimer’s drug approved by the FDA in nearly 20 years, which was welcome news for many patients and organizations. The Alzheimer’s Association called the approval “the beginning of a completely new future for Alzheimer’s treatments.”