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