On Monday, The US Food and Drug Administration gave their approval to the use of experimental drug Aducanumab for treating Alzheimer’s. This is the first medicine approved in over 20 years for this particular disease. Nevertheless, that’s not the main talking point amongst the experts right now. To understand the true significance of this move, we have to go back to last year. Last year, FDA formed an advisory committee to carry out research on this very drug, and the committee concluded from their research that there was not enough evidence to support the effectiveness of the treatment. Now, approving the same drug a year later has got FDA embroiled into a massive controversy. In addition, FDA had given the green light to Aducanumab through their “accelerated approval” program, something that has raised even more eyebrows. While the administration has defended itself by using the argument that life-threatening diseases like Alzheimer’s require speedy approval, some experts are not buying it.
“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward,” the director of FDA’s center for Drug Evaluation and Research, Dr. Patrizzia Cavazzoni said during the announcement, noting that the FDA ultimately decided to use accelerated approval and “concluded that the benefits of Aducanumab for patients with Alzheimer’s disease outweighed the risks of the therapy.”
Now the drug companies are expected to carry out post-approval studies of the drug, known as Phase 4 confirmatory trials. The purpose of these trials is to verify that the approved treatments have the required amount of clinical benefit. If these verification trials do not find the benefits of a drug, then FDA reserves the power to order removal of the drug in question from the market.
In a bid to explain why FDA made a turnaround with the drug after the advisory committee voted unanimously against it, Patrizzia Cavazzoni stated that a string of in-depth studies showed that the drug “consistently and very convincingly reduced the level of amyloid in the brain in a dose”. This revelation indicated towards the reduction of the Alzheimer’s overall impact on the patient’s body, thus encouraging the FDA to test out the waters with this new drug.