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.
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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.
Keeping Track: Cloudy Horizon For Teplizumab, Roxadustat; Nuplazid Stumbles Over Subgroups; CAR-T Submissions From Gilead, J&J
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Use of expedited pathway for Biogen's Alzheimer's drug was discussed at a center director briefing in late April, where it garnered backing from several senior CDER officials, as well as CBER director Peter Marks and OCE director Richard Pazdur.