CLEVELAND — The Cleveland Clinic decided it won't administer a new Alzheimer's drug recently approved by the U.S. Food and Drug Administration.
Aduhelm (aducanumab) is the first new medication to treat patients with Alzheimer’s disease in nearly two decades. It's the first treatment aimed at stopping the progression of the disease rather than treating the symptoms of dementia.
"A multidisciplinary panel of Cleveland Clinic experts have reviewed all available scientific evidence on this medication. Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time. 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 Cleveland Clinic wrote in a statement Thursday.
The New York Times first reported that the Cleveland Clinic along with Mount Sinai’s Health System in New York City, which are among the largest health systems in the U.S., will not carry the drug.
Health experts expressed their concerns with Aduhelm before it was approved by the FDA on June 7.
An FDA advisory committee declined to endorse the drug in November after questioning its effectiveness. Of the panel's 11 members, eight voted against it, saying there were "red flags" in the data. Two members were undecided.
“Alzheimer’s treatment is a huge, urgent, unmet need,” panelist Dr. Joel Perlmutter, of Washington University School of Medicine, said in November. “But if we approve something with data that is not strong, we have the risk of delaying good, effective treatments.”
In the clinical trials, patients taking aducanumab showed their thinking skills decline 22% more slowly than patients not taking it.
Although there were concerns, others were excited, saying the drug paves the way for more treatment options for Alzheimer's patients in the future.
“This approval is significant in many ways,” Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, wrote in a statement in June. “Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain."
The drug was developed by Massachusetts-based biotech company Biogen and Japan’s Eisai Co., and it's a monthly intravenous fusion.
When the FDA granted approval, it did so on the grounds that Biogen must “conduct a post-approval clinical trial to verify the drug’s clinical benefit.”
In the latest fallout over the drug, Dr. Janet Woodcock, the acting head of the FDA, called for a government investigation on July 9 into the highly unusual contacts of the drug reviewers as well as Abuhelm.
“We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures,” Woodcock stated on Twitter.
As of this year, more than 6 million Americans age 65 and older are living with Alzheimer's dementia, according to the Alzheimer's Association. In Ohio, more than 220,000 residents are living with the disease. That number is expected to rise more than 13% in 2025.
Spectrum News' Ryan Chatelain and the Associated Press contributed to this story.