FDA experts resign in protest at controversial approval of new Alzheimer's drug
White Oak, Maryland - The Food and Drug Administration is going ahead with a new Alzheimer's drug that 10 out of 11 experts voted against, which led to three of them resigning their positions immediately.
The new drug from Biogen is called Aduhelm (aducanumab), and as ArsTechnica reports, the FDA committee tasked with going through all of Biogen's provided data for the drug decided fairly unequivocally that the drug was a no-go from the start.
Comprised of 11 experts, when asked if Biogen provided sufficient evidence of efficacy, 10 voted "no" with the 11th voting "uncertain".
When the FDA went ahead and approved the drug last Monday, three of the experts unceremoniously quit in protest.
In response, the FDA cited a possible "surrogate endpoint" behind its approval, meaning that the organization believes that a post-approval trial should prove the drug could do what Biogen claims it can do.
The drug can be prescribed by doctors anyway
In this case, the pharmaceutical company says that Aduhelm will reduce a type of plaque build up called amyloi beta plaque in the brains of some Alzheimer's patients, which contributes to cognitive decline.
"This reduction in plaques is reasonably likely to result in clinical benefit," said the director of the FDA's Center for Drug Evaluation and Research, Patrizia Cavazzoni in a statement.
Aaron Kessleheim, one of the three experts to quit, is a Harvard Medical School professor and director of the Program on Regulation, Therapeutics, and Law at Brigham and Women's Hospital. In his letter of resignation, he claimed the decision on Aduhelm was "probably the worst drug approval decision in recent US history".
Kesselheim even noted that the FDA specifically told the committee it wouldn't consider the effect of how the medication clears brain plaque in its approval process.
And though Biogen has to still prove efficacy in trials, the company has almost a decade to submit that data. In the meantime, the drug can be prescribed to patients, if they are able to shell out $56,000.
Cover photo: collage: 123RF/iqoncept & Kacso Sandor