(RxWiki News) As controversy surrounding a newly approved Alzheimer's treatment continues, the US Food and Drug Administration (FDA) is defending its decision to approve the drug.
In an article published in the July issue of JAMA Internal Medicine, high-ranking officials from the FDA argued that the approval of Aduhelm (aducanumab) was warranted under current guidelines. Aduhelm was the first Alzheimer's disease medication approved in 18 years.
Why are FDA officials defending their decision to approve this drug? Because the approval was met with significant pushback from others in the medical community. Shortly after the approval, three experts from an FDA advisory committee that advised against approving the drug resigned from their positions.
According to those who are pushing back against the approval of Aduhelm, the drug was approved as a treatment for Alzheimer's disease regardless of which stage of disease progression patients are in. Meanwhile, the medication was only studied in those who had mild Alzheimer's. Since then, the FDA has begun restricting the use of this drug to those who have a mild form of the disease.
Perhaps more concerning to some health experts was the assessment that Aduhelm strongly suggested that it could reduce cognitive decline in those with Alzheimer's disease, but the totality of the evidence was not convincing enough to warrant approval.
Despite these concerns, the FDA approved this medication via its accelerated approval pathway in early June. This accelerated approval is the key to the FDA's counter-argument for why it approved Aduhelm.
According to FDA officials, accelerated approval — which is different from a full approval — can be used to push forward drugs that might have beneficial effects for those with serious diseases.
"Accelerated approval is intended to provide earlier access to drugs for serious diseases when there is residual uncertainty at the time of approval regarding the drug's ultimate clinical benefit," wrote the authors of the FDA comment.
The FDA argued that Aduhelm qualified for accelerated approval.
This back-and-forth controversy appears likely to continue, so what is the takeaway for patients? It's always best to discuss your condition with your health care provider so they can recommend the best treatment for your unique case.
If you have questions about Aduhelm or any other Alzheimer's treatment, speak with your doctor or community pharmacist.