An implanted device for delivering the GLP-1 receptor agonist exenatide to people with type 2 diabetes received a unanimous no vote from an FDA advisory panel based on safety and other concerns.
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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. I voted yes but had my finger over the no button for a long time, said Jack Yanovski, MD, PhD, chief of the Section on Growth and Obesity at the National Institute of Child Health and Human Development in Bethesda, Maryland.