Provention Bio announced it completed the teplizumab rolling BLA submission for the prevention of T1DM in at-risk patients. Recall, in August 2020, FDA granted Breakthrough Therapy Designation for the teplizumab T1DM prevention indication. Below, FENIX provides thoughts on the potential Provention Bio missed filing deadline opportunity.

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.

Yesterday, Provention Bio announced the appointment of John K. Jenkins, MD (pictured below) to the company’s Board of Directors. Prior to Provention Bio, Jenkins worked at FDA for 25 years and served as Director of the Office of New Drugs for 15 years. Below, FENIX provides brief thoughts on Jenkins’s appointment.