Provention Bio Files Teplizumab Clinical Module; ADA 2021 PDUFA Possible?
Here is a brief preview of this blast: Provention Bio announced it has filed the clinical module for the teplizumab rolling BLA submission. Recall, teplizumab received Breakthrough Therapy Designation for the prevention or delay of T1DM in at-risk individuals (view previous announcement). The company continues to plan for the final CMC module to be submitted in Q4 '20. Provention Bio previously indicated they are preparing for a 2021 launch, assuming FDA grants priority review (previous FENIX insight). Below, FENIX provides brief thoughts on teplizumab and the impending FDA review.