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Provention Bio’s Teplizumab Delays Type 1 Diabetes Onset, US FDA Says

 
• By Sue Sutter

Advisory committee to consider whether two-year delay is clinically meaningful and substantial evidence standard is satisfied; notably, panel input is not requested on an issue that has tripped up BLA review - bridging data that suggest pharmacokinetic differences between the clinical trial and commercial drug products.

Alarm clock delay
In the pivotal trial, teplizumab delayed the diagnosis of type 1 diabetes by 2 years. • Source: Alamy

The US Food and Drug Administration will ask its external experts whether Provention Bio, Inc.’s teplizumab provides a clinically meaningful delay in onset of type 1 diabetes and satisfies the “substantial evidence of effectiveness” standard based upon a single well-controlled trial and confirmatory evidence.

At a 27 May meeting, the Endocrinologic and Metabolic Drugs Advisory Committee also will discuss how the indicated population should be described in labeling and safety issues identified in the clinical development program

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