FDA

HIGH COUNTRY — The U.S. Food and Drug Administration has approved the first new treatment for Alzheimer’s, a disease affecting millions of Americans, since 2003.

For Amber Chapman, family caregiver and health promotion specialist for the High country Area Agency on Aging, the approval of Aduhelm means hope for families and their caregivers.

The drug, Aduhelm (aducanumab), was approved on June 7 using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments, according to the FDA.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that currently available therapies only treat symptoms of the disease while this treatment option is the first therapy to target and affect the underlying disease.

“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” Cavazzoni said in the statement. “As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”

According to the FDA, Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks.

“We recognize the toll that Alzheimer’s has on so many lives, including those directly impacted by the illness and their loved ones and caregivers,” AppHealthCare spokesperson Melissa Bracey said. “We look forward to learning more as conversations continue around the FDA decision. For now, we plan to connect with other health care partners and our state and federal partners to learn more.”

Specific causes of Alzheimer’s disease are unknown, according to the FDA, but it is characterized by changes in the brain—including amyloid plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections.

According to the FDA, researchers evaluated Aduhelm’s efficacy in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease.

“We have not had a new FDA approved drug for Alzheimer’s in almost two decades,” Chapman said. “However, there is still more work to be done. The FDA has approved the drug but they are still requiring Biogen to do more clinical trials to determine the actual benefit. This drug is meant to slow down the progression of the disease which would be incredible for caregivers and the older adult who is living with Alzheimer’s.”

Under accelerated approval provisions — which allows patients suffering from the disease to receive earlier access to the treatment — the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit, according to the FDA. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.

“I think that we need to take this in stride until it is fully approved, but so far it is promising to know the process has started,” Chapman said.

Chapman said that according to data the organization has collected so far, at least 45 people died from Alzheimer’s and dementia related complications last year. According to an in-depth investigation into Watauga County death records for 2020 done by the Watauga Democrat, the number of deaths from Alzheimer’s or dementia related complications made up about 10 percent of all deaths in 2020.

The average age of those who died from Alzheimer’s or dementia-related causes of death in Watauga County was 87 in 2020, according to the death records.

According to the Alzheimer’s Association, approximately 180,000 people 65 and older in North Carolina were estimated to have had Alzheimer’s in 2020. That number is projected to rise 16.7 percent by 2025 to 210,000 people with Alzheimer’s.

“The High Country Area Agency on Aging has always been committed to helping those who are living with Alzheimer’s and their family members,” Chapman said. “We are here to support any decision they make while providing information and assistance. We must stay educated on new treatments/drugs so that we can encourage and support them. However, we are not medical professionals and the best thing to do is for the individual or family member to advocate for themselves and ask their doctor for information on Aduhelm (aducanumab).”

The prescribing information for Aduhelm includes a warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that usually resolves over time and does not cause symptoms, though some people may have symptoms such as headache, confusion, dizziness, vision changes, or nausea, according to the FDA.

The FDA stated that another warning for Aduhelm is for a risk of hypersensitivity reactions, including angioedema and urticaria. The most common side effects of Aduhelm were ARIA, headache, fall, diarrhea and confusion/delirium/altered mental status/disorientation.

More information on Aduhelm can be found at tinyurl.com/rwp8sbpr.

Chapman said she recommends lifestyle modifications and prevention to maintain health and wellbeing. She said diet, exercise, sleep, stress management and social connections will help everyone age well and is the best way to prevent age-related diseases and injuries.

“We would like to encourage you and your family members to do research on the new drug and talk to your provider about it,” Chapman said. “There is more work to be done for Aduhelm (aducanumab) to be completely approved, but there is hope.”

The High Country Area Agency on Aging serves Alleghany, Avery, Ashe, Mitchell, Watauga, Wilkes and Yancey counties and is a hub for resources and support for older adults in the North Carolina High Country, according to its website. More information and resources can be found at www.highcountryaging.org/resources/resource-guide.

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