PRVB - Provention Bio gives update on teplizumab BLA FDA feedback

Provention Bio (PRVB) said that the U.S. FDA has notified the company of "identified deficiencies" related to its ongoing review of the company's Biologic License Application ((BLA)) for teplizumab for the delay or prevention of clinical type 1 diabetes.The health regulator indicated that based on the data it has reviewed to date, the FDA's position is that the PK profiles of the two drug products evaluated in the PK/PD bridging study were not comparable and that additional data would be required before the FDA's considerations could be satisfied.The FDA intends to continue the review of clinical data submitted in the BLA and to conduct an Advisory Committee meeting, scheduled on May 27, 2021.The agency also stated in the correspondence that the notification does not reflect a final decision on the information under review.The company said that the FDA's feedback could likely result in a delay in timelines for the approval

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Provention Bio gives update on teplizumab BLA, FDA feedback