A confirmatory trial for a new Alzheimer’s disease drug is many years away, Elizabeth Tracey reports

June 22, 2021


Medicare is poised to spend millions of dollars on aducanumab, a just approved drug for Alzheimer’s disease the FDA’s own advisory panel recommended against approving. Caleb Alexander, a member of the panel and an internal medicine expert at Johns Hopkins, says approval was reached using what’s known as the accelerated pathway.

Alexander: For products that are approved using the accelerated pathway they’re approved on the basis of a surrogate or a biomarker, in this instance brain amyloid levels. So when products are approved using the accelerated pathway the manufacturer is obligated to conduct what’s called a confirmatory study, a study that looks at the outcomes that we really all care about, that is clinical benefit however those types of studies can take several years to perform.  :28

Alexander notes that a confirmatory study could be about nine years in the future, enabling Biogen to market the drug and reap enormous profits in the meantime. At Johns Hopkins, I’m Elizabeth Tracey.

Previous post:

Next post: