FDA approval of new Alzheimer’s drug is fraught with controversy

FDA approval of new Alzheimer’s drug is fraught with controversy

By Paula Hartman-Stein, Ph.D.
August 3, 2021 - Last updated: August 2, 2021

The conditional approval in June by the Food and Drug Administration (FDA) of Biogen’s drug, aducanumab, the first new medication since 2003 to treat Alzheimer’s disease, was met with a flurry of praise for giving hope to the millions living with dementia and criticism by many researchers, the geriatric medicine community and watchdog groups.

In the winter of 2020, the FDA refused to approve aducanumab, marketed as Aduhelm, a monoclonal antibody. In November, an independent group of FDA advisors reviewed clinical data and concluded there was insufficient evidence the drug would significantly improve patients’ cognition or functioning.

The FDA granted conditional approval based on Aduhelm’s ability to clear the protein, beta amyloid, that clusters to form plaques in the brain, suspected as the leading cause of Alzheimer’s.

Patients receiving Aduhelm over 78 weeks had about a 30 percent reduction in amyloid based on brain scans compared to patients receiving a placebo. However, 40 percent of patients in the drug trial developed brain swelling and bleeding.

Three FDA panel advisors resigned after the controversial drug approval.

Michael Carome, M.D., director of Health Research for the watchdog group Public Citizen, said in a statement: “The FDA’s decision shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.”

The $56,000 per patient per year that Aduhelm costs could generate billions in annual sales for Biogen.

The Alzheimer’s Association welcomed the approval of Aduhelm but criticized its cost.

“This price is simply unacceptable,” the organization said. “For many, this price will pose an insurmountable barrier to access. It complicates and jeopardizes sustainable access to this treatment and may further deepen issues of health equity.”

The next hurdle for the drug will be whether the Center for Medicare and Medicaid will agree that Medicare should pay for the drug, the gold standard that influences other insurance companies’ decisions to reimburse new treatments.

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