Posted by Michael Wonder on 02 Oct 2020
Provention Bio files clinical module for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals
30 September 2020 - Expect to complete filing of the rolling biologics license application for teplizumab in Q4 2020.
Provention Bio today announced the submission of the clinical module of the Company's biologic license application to the U.S. FDA for teplizumab (PRV-031), an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical Type 1 diabetes mellitus in at-risk individuals.
