Provention was flying high on Tuesday when an FDA advisory panel seemed to back the efficacy of its diabetes prevention drug, even after the agency flagged some issues with the data package supporting the therapy’s application a month earlier. But the company is not out of the woods yet, with the final vote only narrowly supporting the drug’s approval Thursday afternoon.
The Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 that the benefits of teplizumab outweighed its risks, with many panelists “struggling” to come down on one side or the other. Provention is seeking approval for the drug, teplizumab, for the delay of Type 1 diabetes in at-risk patients.
Author: Canan Schuman, PharmD/PhD
Canan Schumann is Chief Editor for Axxiem and for Axxiem's blog "BiotechOntheWeb". When not writing for Axxiem, Canan works as a Clinical Research Scientist II at the Research and Development Department at Molecular Testing Labs, developing endpoint assays for the detection of infectious disease and cancer. Canan currently resides in Portland, Oregon, where he received his Honors Bachelor of Science (HBS), Doctor of Pharmacy (PharmD.), and his Doctor of Philosophy (Ph.D.) in Biopharmaceutics at Oregon State University.