FDA adcomm votes in favor of approving Provention Bio’s drug to delay type 1 diabetes
Following heated discussions on the small but positive pivotal trial, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Thursday voted 10-7 in favor of the FDA approving Provention Bio’s teplizumab for the delay of clinical type 1 diabetes in at-risk individuals.
Committee members seemed swayed by the clearly highlighted quality of life improvements in the public discussion, but with some question marks in the safety data and the confirmatory evidence, the panel went back and forth on what the data actually show – setting up a tough decision for the FDA by July 2. The FDA does not have to follow the advice of its adcomm, but it usually does.
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