Provention Bio announced that yesterday, the company launched a national campaign to bring awareness to the importance of screening people with a family history of T1DM. The campaign is made of two complementary modules: Connected by T1D (for providers) and Type 1 Tested (for patients). The campaign initiation follows Provention’s announcement that the clinical module for the teplizumab BLA rolling submission has been submitted to FDA, leaving only the final CMC module to be submitted later this year. Below, FENIX provides thoughts on the campaign in the context of the FDA review of teplizumab.

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.