May 28, 2021 | MedpageToday
Drug to Delay T1D Gets Tepid Endorsement by FDA Advisors
From Medpage Today:
Teplizumab got a reticent thumbs-up from FDA advisors for an indication in delaying progression of at-risk patients to clinical type 1 diabetes (T1D).
The agency's Endocrinologic and Metabolic Drugs Advisory Committee on Thursday voted 10-7 that sufficient evidence of benefit outweighed the risks for this novel biologic.
However, a number on both sides indicated how narrowly they had come to making the opposite decision.
Susan Ellenberg, PhD, a biostatistician at the University of Pennsylvania in Philadelphia, voted yes despite struggling with the data. "I was pushed by the very encouraging results of what is admittedly a small study and something that I can't really feel is completely definitive. But I would not like to deny people who are the kind of people we heard from today to weigh their own risks and benefits to try this."