In June, the U.S. Food and Drug Administration approved Biogen's Aduhelm, the first Alzheimer's medication in nearly 20 years.
Aduhelm does not reverse mental decline. It only slowed it in one study. The FDA ultimately granted the drug conditional approval based on its ability to get rid of harmful clumps of plaque in the brains of patients with early forms of the disease.
While some clinics have already started giving the drug, many providers say it will take weeks or months before they are ready. Insurers, including Medicare, are still trying to determine which patients to cover for a treatment that could cost more than $50,000 a year.
Harry Johns, president and CEO of the Alzheimer’s Association, heralded the FDA's approval of the drug.
"This is the first ever FDA-approved treatment for the underlying biology of Alzheimer’s, not just the symptoms," Johns said in a news release. "Slowing the progression for those with mild cognitive impairment due to Alzheimer’s disease or Alzheimer’s dementia in the earliest stages offers the potential for more precious time for diagnosed individuals and their loved ones.”
The FDA has not approved a novel therapy for Alzheimer’s disease since 2003. Aduhelm is the first therapy to demonstrate that removing the amyloid plaques from the brain may delay decline in those with Alzheimer’s. Amyloid plaques are abnormal levels of naturally occurring proteins that clump and form plaques and disrupt cell function.
According to the Alzheimer’s Association, Aduhelm is administered intravenously through a 45- to 60-minute infusion every four weeks at hospitals, infusion therapy centers or at home by specialized nurses.
This therapy, studied in those with early Alzheimer’s disease and MCI due to Alzheimer’s who showed a buildup of amyloid plaques in the brain, has not yet been tested on those with more advanced cases of dementia.
It is not a cure, and there is no evidence it can restore lost memories or cognitive function.
However, by slowing the rate of decline, Aduhelm offers affected individuals more time to actively participate in daily life.
Those interested in receiving the medication should contact their physician to determine eligibility.
Dr. Julia Biemot, assistant professor of neurology at the University of Maryland School of Medicine, recently told CNN: "I would personally not prescribe the drug unless there is biomarker evidence of amyloid positivity, along with clinical symptoms of Alzheimer's disease. Ultimately, there are many factors to consider when deciding to treat a patient with a newly approved medication, especially when there is some uncertainty about its clinical benefit. There may be a subgroup of patients that benefits from this drug. My own decision to prescribe it will be made in collaboration with the patient, and based on the patient's age, imaging findings to rule out contraindications, type and severity of symptoms, risk factors and overall diagnostic impression."
For more information about Aduhelm, contact the Alzheimer’s Association at alz.org.