In a "striking reflection of concern" about Biogen's newly approved Alzhiemer's drug, Aduhelm, Cleveland Clinic and Mount Sinai Health System on Wednesday said in separate statements that they will not administer the medication to patients.
Biogen originally sought FDA approval for the drug—called aducanumab and branded Aduhelm—in 2019. According to a company analysis of clinical trial data, a high dose of aducanumab slightly slowed cognitive decline in patients with mild Alzheimer's. However, that study was halted after an initial analysis of the data had found the drug was unlikely to benefit patients, and a separate clinical trial had found no effect on cognitive decline.
In 2020, a panel of independent experts convened by FDA reviewed the clinical trial data. They determined there was not enough evidence to suggest the treatment had significantly benefited patients, and they recommended against approval. Some patient groups, however, advocated strongly for approval, especially because Alzheimer's patients have few other medical options to slow their cognitive decline.
Ultimately, FDA issued a conditional approval that requires Biogen to conduct a large clinical trial to confirm that aducanumab actually leads to cognitive benefits for patients. If that trial fails, FDA could rescind the drug's approval.
Earlier this month, FDA narrowed its approval for the drug to only Alzheimer's patients with early-stage symptoms of the disease, rather than for all Alzheimer's patients. In addition, acting FDA Commissioner Janet Woodcock called on HHS' Office of the Inspector General (OIG) to investigate the drug's approval process.
In a statement, Cleveland Clinic said a panel of experts at the organization had "reviewed all available scientific evidence on this medication" and that "[b]ased on the current data regarding its safety and efficacy … [it] decided not to carry aducanumab at this time." However, the organization said when "additional data become available," it may "re-evaluate this medication for use in our patients."
A Clinic spokesperson added that while providers at the organization could still prescribe the drug, patients would have to go elsewhere to have it administered. The drug is administered via infusion once per month.
Separately, Sam Gandy, director of Mount Sinai Center for Cognitive Health, said Mount Sinai would similarly refrain from administering the medication. According to Gandy, the organization made the decision based on concerns about FDA's approval of the drug.
"Aduhelm will not be considered for infusion into patients on any of [Mount Sinai's] campuses until and unless" an IOG investigation "affirms the integrity of the F.D.A.-Biogen relationship and goes on to reaffirm" FDA's approval process for the drug, he said.
Separately, Woodcock on Wednesday in an interview at STAT's Breakthrough Science Summit said that although she believes in the drug's approval and in the drug itself, her agency may have mishandled the approval process.
"The accelerated approval was based on very solid grounds," Woodcock said. "I do believe that will play out over time, as people see that was a very appropriate use of that authority and the right thing to do for patients."
However, she added, "Was the process done exactly the best that it could be? Possibly not."
Woodcock also defended FDA's decision to initially approve the drug for Alzheimer's patients whose symptoms were more serious than those of patients included in the drug's clinical trials, noting that it is common for the agency to issue broader approvals for drugs treating neurodegenerative diseases. That said, she added, "In this case I think after getting feedback, they realize they should be more descriptive about who was in the trial and what was known about those not in the trial." (Belluck, New York Times, 7/14; Cohrs, STAT News, 7/14; WKYC, 7/15)
In April, FDA’s Oncologic Drugs Advisory Committee met to review the status of six checkpoint inhibitor indications granted accelerated approval over the past five years, ultimately recommending just two of the six indications be withdrawn from the market. Read on as Advisory Board’s Lindsey Paul and Ashley Riley outline the four key takeaways from the review.
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