The first new medication for Alzheimer’s disease in almost 20 years seems to reduce the amount of amyloid peptide in the brain, which may slow the progression of the disease.A drug approved today by the United States Food and Drug Administration for Alzheimer’s disease may help slow the progression of the disease in patients with mild or early forms of cognitive impairment, but it is not a cure for Alzheimer’s disease.
Aducanumab, known commercially as Aduhelm, gained FDA approval and is the first new therapy for AD approved in almost 20 years. It targets AD with a mechanism completely different from those of previously approved therapies. Aducanumab is the first drug to be approved that is shown to reduce brain amyloid, a sticky protein that accumulates in AD.
“The approval of the first disease-modifying therapy is a milestone for our field and a result of years of intense research. However, it must be understood that Aduhelm is not expected to restore memory or reverse the symptoms of Alzheimer’s disease,” said David Geldmacher, M.D., professor of neurology at the University of Alabama at Birmingham and Clinical Core director for the UAB Alzheimer’s Disease Center. “Instead, it is expected to slow the worsening of the disease. Aduhelm is likely the beginning of a new era in treating AD, but not the end of the story.”
UAB’s Division of Memory Disorders and the Alzheimer’s Disease Center have been involved in clinical trials of Aduhelm for the past five years.
Clinical trials have shown that, with high doses of Aduhelm, patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease showed a reduction in the amount of amyloid in the brain. The clinical trials results were less clear about the drug’s effects on cognitive decline, and the FDA approval today requires Biogen to conduct further studies to verify the drug’s clinical benefit.
Today’s FDA action allows the manufacturer of the drug, Biogen, to begin to manufacture the drug and make it available to clinicians.
David Geldmacher, M.D., professor of neurology at the University of Alabama at Birmingham and Clinical Core director for the UAB Alzheimer’s Disease Center.
(Photo by: Steve Wood)“It may be some time before Aduhelm is widely available, and not all patients will be eligible for it or should expect to see benefit,” Geldmacher said. “In particular, patients with advanced disease are not likely to see improvement from the drug.”
The medication is given via an IV infusion, and patients will need to be monitored for potential serious side effects, including bleeding in the brain. Additional biomarker testing will most likely be necessary before the drug can be prescribed.
Medicare has not published its decision on who will be eligible to receive the drug under Medicare or Medicare supplemental insurance programs.
“It may provide important benefits for some people,” Geldmacher said. “It leaves the door open to find even better treatments, and that’s the focus of our ongoing research. This is not a door closing on the research process. This is a door opening on new ways of treating AD, maintaining brain health, and reducing the disability and caregiving challenges associated with Alzheimer’s disease.”
UAB Hospital has expanded staffing in the memory clinics to prepare for the increased demand for services that are expected to result from the FDA’s decision.