After 17 years of hope and frustration, the decision over whether to approve, at last, a new treatment for Alzheimer’s disease could come down to eight people sitting in a suburban hotel ballroom.
Biogen is planning to seek Food and Drug Administration approval for a once-disregarded drug, and if everything goes according to plan, the company will have a date with the agency’s Peripheral and Central Nervous System Drugs Advisory Committee. That revolving group of outside experts is one of about 50 committees tasked with voting on whether the FDA should approve a product. The results aren’t binding, but experts’ opinions can sway how regulators rule on controversial applications.
Biogen’s drug, aducanumab, is particularly controversial. And that means the FDA’s panel of advisers could wield significant influence when it comes time to consider approval, experts said. One prominent expert believes that any decision to convene an advisory panel would be a telltale sign of the likely outcome.
since you neglected to provide any details about the relevant FDA Advisory Committee, I decided to included it above.
Now as anyone can see, there are currently 11 members on the Committee roster. I would like you to explain to all readers what did you mean precisely by “Eight Experts”? Which are the Eight that “would wield extraordinary influence” ? Which three would not? Why? How did you come up with that o? Does Biogen agree with your assessment?
To be a thoroughly useful article and a responsible jorunalsit, you should have listed the names and affiliation of the members of the Peripheral and Central Nervous System Drugs Advisory Committee, or at least a link to the Committee on the FDA website.
There is also a parallel with the 2016 approval pimvanserin–the drug for delusions and hallucinations in Parkinsons patients. Approval was based on one small trial w a lot of methodological problems; two other trials were negative. The primary medical reviewer at FDA recommended against approval but the company prevailed.
thanks for pointing out the Duchenne MD parallel Damian. This was the first thought to cross my mind when I heard Biogen was going to file. FDA set a terrible precedent, and IMO this move by Biogen is a clear consequence.
There will definitely be an Ad Comm, if for no reason than to provide political cover.
Maybe there is convincing data in the second Phase III, but I’ll believe it when I see it.
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