Provention Bio’s Teplizumab Delays Type 1 Diabetes Onset, US FDA Says
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.
You may also be interested in...
Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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.