US FDA Panel Nod For Teplizumab To Delay Type 1 Diabetes Comes On Strength Of Single Study

 
• By Sue Sutter

Advisory committee members say Provention Bio’s meta-analysis of biomarker data from other type 1 diabetes trials cannot serve as confirmatory evidence to satisfy the ‘substantial evidence’ standard, creating a potentially awkward situation for the agency when it comes to making an approval decision.

Boy with insulin
The panel majority found sufficient evidence that teplizumab delays the onset of type 1 diabetes. • Source: Alamy

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