Provention Bio slapped with FDA rejection for diabetes hopeful teplizumab

After scraping through a tough advisory committee in March, the FDA has returned a verdict for Provention Bio’s Type 1 diabetes medicine: It’s a no.

Specifically, the FDA has slapped a complete response letter on Provention for teplizumab, which was gunning for an approval to help delay clinical Type 1 diabetes in at-risk individuals.

In the trial that underpinned the drug’s application, Provention said teplizumab delayed the onset of Type 1 diabetes by a median of two years. That delay could help patients avoid diabetic ketoacidosis, a life-threatening complication of diabetes.