BREAKING: FDA approves first drug to slow Alzheimer’s in controversial decision
In a landmark decision, the Food and Drug administration has approved the Alzheimer’s disease drug aducanumab (Brand name: Aduhelm). The decision sets the stage for it to become the first-ever drug marketed to slow progression of the brain-wasting disease, according to developer Biogen.
The FDA had not approved a new Alzheimer’s drug since 2003 and various experts have stacked up against this one, including at least a few leading long-term care experts.
With this approval, clinicians say they may be caught between concerns about aducanumab’s efficacy, safety, accessibility and affordability, and the needs of patients who feel they have no other recourse.
“The FDA’s decision is an unfortunate and ill-advised one” for residents with Alzheimer’s and their families, Karl E. Steinberg, M.D., president of AMDA – The Society for Post-Acute and Long-Term Care Medicine, told the McKnight’s Clinical Daily.
“There are so many factors that make it a bad choice,” he said. The drug has limited effectiveness considering its potential dangers, he added. It is not yet clear how the drug will be rolled out and to which populations initially, and it is expected to be expensive for some patients and for Medicare.
Although as a geriatrician he sympathizes with persons with dementia and family members who are desperate for an effective treatment, Steinberg said he would not be comfortable recommending the drug, and would not personally prescribe it at this time. “I see the devastation that [Alzheimer’s] wreaks every day, but this is not the answer to that,” he added.
“I don’t think it will be as much of an issue in skilled nursing facilities [due to initial lack of access], but I do think that there will be a not insubstantial population who will be clamoring for it. I know there are a lot of doctors who have said they will not prescribe it.”
Other long-term care physicians agree.
“I know that people with a chronic and terminal disease like Alzheimer’s can be desperate to try anything that might modify the course of the disease, but I think the evidence for the efficacy of aducanumab is quite limited,” Kevin O’Neil, M.D., FACP, CMD, chief medical officer of ALG Senior, told the McKnight’s Clinical Daily.
“It is certainly not a cure for Alzheimer’s disease and likely won’t be helpful in those with advanced disease. Personally, I would wait for more research to prove its efficacy and safety,” the senior living physician added. “Also, it needs to be affordable. Out-of-pocket costs for the drug could be thousands of dollars.”