A newly approved drug for treating Alzheimer’s disease received a mixed reception. The Food and Drug Administration granted accelerated approval for Aduhelm on Monday. This is the first new Alzheimer’s drug approved in almost 20 years.
Studies show that Black elders are disproportionately more likely much as twice as likely as their white counterparts to develop the disease. Despite the increased risk for Alzheimer’s, Black patients have been traditionally underrepresented in clinical trials and observational studies. A March 2020 fact sheet from the Alzheimer’s Association, Black and Latino Alzheimer’s patients are often diagnosed in later stages of the disease.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the newly approved drug provided an opportunity to treat the underlying disease process. “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,” said Cavazzoni in a 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.”
In its announcement, the FDA said it would require the drug’s manufacturer, Biogen, to “verify the drug’s clinical benefit” with a new randomized controlled clinical trial. According to the Associated Press, the company plans to complete the follow-up trial by 2030.
The Alzheimer’s Association explained the approval provided a new treatment that could potentially delay decline. It is not for more advanced cases. “Approval of this therapy underscores the importance of early detection and diagnosis to ensure individuals receive the most benefit as soon as possible,” read the Alzheimer’s Association’s website.
Yet, some public health officials expressed concern over the new drug’s rapid approval, citing potential issues with effectiveness and cost.
A year’s treatment of the new treatment costs about $56,000. In theory, insurance and other programs would handle most of the costs for patients. But even paying a small percentage could prove cost-prohibitive for some patients.
Caleb Alexander, an epidemiologist who served on the advisory panel that voted against Aduhelm, told STAT that the decision was surprising. “The most compelling argument for approval was the unmet need, but that cannot, or should not, trump regulatory standards,” said Alexander. “Unmet need is an important contextual factor, but it’s not an evidentiary threshold.”
STAT News reported the FDA’s approval could go down as one of the most controversial decisions in recent history after an independent panel of experts objected last November. Reviewing Biogen’s data, the panel found insignificant evidence to support approval.
Still, the possibility of new treatment offers hope to many patients and families. A leading cause of dementia, about six million people have Alzheimer’s in the United States.