"First of Its Kind"
A "potential blockbuster" halting a thief of time, or an imposter of hope?
The FDA approves the first treatment for treating what some believe is the cause of Alzheimer's, not just the symptoms. So why did some of the FDA's experts recommend against its approval?
Here's what to know.
What It Is:
- The Treatment: aducanumab (add-yoo-CAN-yoo-mab)
- Context: Alzheimer's disrupts memory and other brain functions. It remains a mystery as to why someone might develop the disease. One theory: naturally-occurring proteins can clump together, causing "plaque" that disrupts brain function.
- What Does It Do? This antibody treatment breaks apart this plaque; *however,* some question whether that alone will help improve symptoms of the disease.
- Cost: Out-of-pocket expense may be $10,000 or higher; also requires a brain scan - which may not be covered by insurance - to see if a patient has early evidence of the plaque.
- Logistics: Administered by doctors as a monthly infusion, rather than the ease of a pill prescribed at a pharmacy.
- Potential Side Effects: Brain-bleed, swelling. Extensive monitoring recommended.
- Limited Use: For those with early symptoms.
“There’s so little evidence for effectiveness. I don’t know what caught the FDA’s fancy here.”
Dir. of the California Alzheimer's Disease Center at the University of Southern California, Dr. Lon Schneider, who helped conduct trials for aducanumab. The drug received "accelerated approval" without final trials completed. Initially manufacturer Biogen stopped trials, with concerns the treatment did not work - only to later realize patients receiving high doses showed slower cognitive decline than others; some say the benefits do not outweigh the risks, costs, and questions.
“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. 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.”
FDA's Dr. Patrizia Cavazzoni on accelerated approval for "serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments."
Jun 7, 2021