Provention Maps Possible Regulatory Path For Troubled Teplizumab
Biotech Aims To Get Type A Meeting With FDA In Q4
Executive Summary
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.
You may also be interested in...
Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keeping Track: US FDA Clears Vaxneuvance, Rezurock And Karendia, But Not Teplizumab
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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.