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FDA Approves ADUHELM™, New Alzheimer’s Disease Treatment

June 09, 2021

Kansas City, Kan. — For the first time in nearly 2 decades, the Food and Drug Administration has approved a new medication to treat Alzheimer’s disease. The drug, ADUHELM™ (aducanumab), is designed to slow cognitive decline in Alzheimer’s disease patients. ADUHELM was tested in people who are in the early stages of the disease and exhibit mild cognitive decline.

“It will change the game on how we diagnose and treat Alzheimer’s disease,” said Jeffrey Burns, MD, Alzheimer's disease specialist at The University of Kansas Health System.

Most current medications for Alzheimer’s disease work by treating the patient’s symptoms. ADUHELM, however, is designed to slow changes in the brain that may cause or influence the progression of Alzheimer's disease, thereby potentially altering the course of the disease itself.

ADUHELM targets amyloid beta plaque – a hallmark protein found in the brain of people with Alzheimer’s disease. Early clinical data supports that a reduction in these plaques is expected to lead to a reduction in cognitive decline. However, more studies are needed to prove the effectiveness of ADUHELM.

“It’s not a cure and will not reverse Alzheimer’s disease,” says Dr. Burns. “But it could help slow disease progression.”

ADUHELM received accelerated approval from the FDA. This fast-tracking program allows for earlier release of drugs to treat serious diseases and fill an unmet medical need. It is not the same as the emergency use authorization, which was used for the COVID-19 vaccine.

In order to gain full FDA approval, ADUHELM’s parent company, Biogen, is required to conduct a post-approval clinical trial to verify the drug’s clinical benefit. The University of Kansas Health System is part of that trial.

“More conclusive data will be collected in the coming years,” Dr. Burns states.

The University of Kansas Health System will be offering ADUHELM to people with Alzheimer’s disease who meet certain criteria. In order to qualify, patients must undergo a thorough evaluation that includes a series of tests, such as cognitive testing, MRI, amyloid PET scan or lumbar puncture. Patients who are good candidates for treatment with ADUHELM will be monitored with MRI scans every 3-6 months.

The University of Kansas Alzheimer’s Disease Center, part of the University of Kansas Medical Center, is home to the region’s only National Institute on Aging-designated Alzheimer’s Disease Research Center and 1 of only 31 nationally designated Alzheimer’s Disease Research Centers in the nation. The medical center collaborates with The University of Kansas Health System to offer more exercise and clinical research drug trials than other hospitals in the region.

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