The U.S. Food & Drug Administration on Monday approved the first drug to slow cognitive decline in patients with Alzheimer’s disease, a historic decision that’s sure to draw controversy within the medical community.
Biogen’s Aduhelm treatment is delivered via intravenous infusion and, in stage 3 clinical trials, reduced amyloid plaque levels in the brain believed to contribute to cognitive decline. The drug, widely known by its scientific name aducanumab, was OK'd by the FDA using its Accelerated Approval pathway and marks the first therapy approved for the neurological disease since 2003.
The Society of Nuclear Medicine & Molecular Imaging, which represents some 15,000 imaging professionals worldwide, came out in support of the approval Monday, saying the “potential benefits of the drug certainly outweigh the risks.”
“The approval of Aduhelm is a great win for patients with Alzheimer’s disease and their families,” President Alan Packard, said in a statement. “We are proud that nuclear medicine can help to support this drug by providing definitive diagnoses and monitoring the effectiveness of the treatment.”
In its announcement, the FDA acknowledged the controversy surrounding its decision, namely an overwhelming vote from a panel of experts against its approval back in November. At that time, the federal advisory committee said that data provided by Biogen were not enough to show Aduhelm could alter the progression of Alzheimer’s.
The FDA, however, said it examined clinical findings with a “fine-tooth comb” and followed its usual course of action for its conclusions.
“Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid-beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients,” Director of the administration’s Center for Drug Evaluation and Research Patrizia Cavazzoni, MD, said June 7.
The Alzheimer’s Association, which has been pushing for the drug’s approval, quickly came out in support of the FDA’s decision. Although it’s not a cure, the move will greatly benefit patients, it said in an email statement Monday morning.
“This approval is a victory for people living with Alzheimer’s and their families,” Harry Johns, president and CEO, said this morning in a tweet from the organization celebrating the decision.
The treatment is approved for patients with early-stage Alzheimer’s who receive a PET scan showing the presence of beta-amyloid in their brains.
Biogen’s stock was halted on the FDA news. And while the biotech company hasn’t disclosed what it will charge for Aduhelm, STAT reported it may cost between $10,000 and $25,000 per year, according to analyst expectations.
Due to accelerated approval nature of this drug, Biogen will have to complete post-approval studies, known as phase 4 confirmatory trials, in order to continue marketing Aduhelm, the FDA explained. If those investigations fail to confirm the drug’s effectiveness, the FDA can pull approval.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.