Posted by Michael Wonder on 09 Apr 2021
Provention Bio provides regulatory update on biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
8 April 2021 - Provention Bio today announced that the company received a notification on 2 April 2021 from the U.S. FDA, stating that, as part of its ongoing review of the company's biologic license application for teplizumab for the delay or prevention of clinical type 1 diabetes, the FDA has identified deficiencies that preclude discussion of labelling and post-marketing requirements/commitments at this time.
The FDA stated in the correspondence that the notification does not reflect a final decision on the information under review.
