Posted by Michael Wonder on 16 Apr 2020
Provention Bio initiates rolling submission of biologic license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals
16 April 2020 - Rolling submission initiated under breakthrough therapy designation.
Provention Bio today announced the initiation of the rolling submission of the Company's biologic license application to the U.S. FDA for teplizumab (PRV-031), an anti-CD3 monoclonal antibody for the delay or prevention of clinical type 1 diabetes mellitus in at-risk individuals, as indicated by the presence of two or more type 1 diabetes related autoantibodies.
Rolling submission allows for completed modules of the application to be submitted and reviewed by the FDA on an ongoing basis. Provention submitted the non-clinical module and expects to submit the clinical module in Q3 and the chemistry, manufacturing and controls module in Q4 of 2020.
