Dr. Selloway, a research director on the site for studies of the drug, was not paid for this work but has received research and consulting fees from Biogen. He said doctors should only use the drug on patients whose status matches those in clinical trials.
“There is no evidence that it could be beneficial for any other stage of Alzheimer’s disease,” he said.
Mary Sano, director of the Alzheimer’s Research Center at Mount Sinai in New York City, said the criteria she and other panelists outlined were “very important”, saying that “it will be very restrictive and the ability to use this drug with.” Sharing a wide range of people with others will be significantly limited, at least at this point in time. “
For dementia clinicians, treating people with only mild symptoms would mean that “most of your staff is unlikely to be an option in your current practice,” said Dr. Sano.
In its decision, the FDA admitted that there was not the proof of benefit usually required by the authorities. As a result, it is making it available to Aduhelm under a program called accelerated approval, which spearheads the drug’s ability to lower amyloid levels in the brain. But reducing amyloid is not the same as slowing down symptoms of dementia. Many amyloid-lowering drugs failed to slow the decline in clinical trials, a story that makes some experts particularly suspicious of trusting Aduhelm based on the evidence presented so far.
Also, given the agency’s focus on amyloid in its approval decision and the fact that all participants in the clinical trial were required to have high levels of amyloid, experts were surprised that the FDA label does not mandate patient screening for the protein. Doctors at the Alzheimer’s Association forum all said that high levels of amyloid, typically measured by PET scans or spinal puncture, should be a prerequisite for treatment.
Several of the panelists said that relatively few doctors and clinics, at least initially, would be able to adequately diagnose, screen, and treat patients.
“This is not a simple drug,” said Dr. Paul Aisen, director of the Alzheimer’s Therapeutic Research Institute at the University of Southern California and co-author of an article calling on the FDA to approve the drug. “I think identifying the right people to treat and supervise treatment requires knowledge and experience, and there are very few clinicians who have that experience.”