Posted by Michael Wonder on 06 Aug 2019
Provention Bio announces breakthrough therapy designation for teplizumab for the prevention or delay of clinical type 1 diabetes in at-risk individuals
5 August 2019 - Provention Bio today announced that the U.S. FDA has granted breakthrough therapy designation to teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes mellitus in individuals at-risk of developing the disease.
The FDA decision was based on clinical data from the "At-Risk" Study conducted by TrialNet, which showed that a single 14-day course of PRV-031 (teplizumab) significantly delayed the onset and diagnosis of clinical type 1 diabetes mellitus, as compared to placebo, by a median of at least 2 years in children and adults considered to be at high risk of developing clinical type 1 diabetes mellitus.
