Fda approves aducanumab to treat alzheimer’s disease


IS THE HEALTH SYSTEM READY FOR THIS BREAKTHROUGH TREATMENT? Not everyone with Alzheimer’s disease will qualify for the drug. One month after aducanumab’s approval, the FDA revised the drug’s

prescribing label, narrowing its intended use to people in the early stages of the disease — about 2 million Americans.   And because the new drug targets amyloid plaques, the presence of

the protein clumps will need to be confirmed. Currently, the only way to know for sure if amyloid plaques are present is with expensive brain scans and spinal taps that some patients may not

be able to access. Simpler blood tests that doctors can also use to detect amyloid and other signs of Alzheimer's disease have proved promising but are not yet widely available.

Another obstacle: Aducanumab, a monoclonal antibody, is an infusion therapy, not a pill. Patients in the trials received the drug intravenously every four weeks at infusion centers, which

makes the treatment less available to individuals who lack transportation or don't live near a site where it's offered. "People who live in urban areas and can get scans and

have a center near them where they could get infusions are [not going to have a problem getting aducanumab]. But that's not who we want to reach — we want to reach all of the patients

who would be qualified for this drug,” Cummings says. “So there's going to have to be an adjustment of the entire health care system to accommodate a really exciting new drug.” The

treatment also comes with some side effects, including temporary swelling in the brain and tiny brain bleeds. This means patients on the therapy will need regular brain scans to ensure

safety, Ronald Petersen, director of the Mayo Clinic Alzheimer's Disease Research Center, told AARP in a previous interview — a step that will require more time, technology and money

from patients and providers. APPROVAL ENERGIZES ALZHEIMER'S RESEARCH Aducanumab's approval will be a boon for Alzheimer's research, Cummings predicts. “Seeing the fact that we

can sort of crack the code of Alzheimer's disease is just so meaningful, because it will attract funding, which will allow us to test more drugs, which will allow us to eventually make

more approvals.” A total of 126 different therapies are currently being tested in clinical trials, according to a recent analysis of the Alzheimer's Association research pipeline,

authored by Cummings. Like aducanumab, some go after amyloid, including three promising monoclonal antibodies that are in the third and final phase of testing. Others explore different

elements of the disease. And many of them — likely even a combination — could be the key to ending Alzheimer's. In the meantime, researchers have made tremendous strides in

understanding how people can reduce their risks for dementia with nonpharmacological interventions. Everything from diet and exercise to blood pressure control can help to preserve brain

health and cognitive functioning throughout the aging process. "AARP continues to support encouraging adults to reduce their risks for cognitive decline as they age and the development

of new innovative research,” says Sarah Lenz Lock, senior vice president for policy and brain health at AARP and executive director of the Global Council for Brain Health. _Editor’s Note:

This story, originally published June 7, has been updated to reflect new information._ _Rachel Nania writes about health care and health policy for AARP. Previously she was a reporter and

editor for WTOP Radio in Washington, D.C. A recipient of a Gracie Award and a regional Edward R. Murrow Award, she also participated in a dementia fellowship with the National Press

Foundation._