RHHBY - FDA Alzheimer's stakeholders look at expediting post-marketing confirmatory trials

kunertus/iStock via Getty Images The FDA and Alzheimer's drug developers are looking at ways to potentially speed up post-marketing confirmatory trials, according to a discussion guide of a meeting held yesterday by the Duke Margolis Center for Public Health. As a condition of the approval of the approval of Biogen's ([[BIIB]] -4.7%) Aduhelm (aducanumab), the company is required to conduct a confirmatory trial with results within nine years. "A key question is whether surrogate endpoint validation can occur in a more expedited way, including through assessing evidence being developed in the other drug trials or through postmarket studies," the document states. The guide also mentions that although the label for Aduhelm was recently narrowed to only early-stage Alzheimer's, the Centers for Medicaid and Medicare Services ("CMS") "could extend limited off-label coverage" to patients with more severe Alzheimer's under the Coverage with Evidence Development program in clinical trials. The attendee list for

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FDA, Alzheimer's stakeholders look at expediting post-marketing confirmatory trials