Provention Bio, Inc. today announced that the resubmitted Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals has been considered a complete, class 2 response to the July 2021 action letter by the U.S. Food and Drug Administration (FDA). The FDA has assigned a user fee goal date of August 17, 2022. The FDA previously granted teplizumab Breakthrough Therapy Designation.
“We are delighted to have received the Agency’s acceptance of our BLA resubmission as a complete response to the July 2021 CRL and are excited to have taken yet another significant step towards the potential approval of teplizumab for at-risk T1D individuals as the first ever disease-modifying therapy to delay the onset of this debilitating and life-threatening disease,” said Ashleigh Palmer, Co-Founder and CEO of Provention Bio. “Today’s announcement is the result of tremendous dedication and hard work by our team, in conjunction with our collaborative and constructive interactions with the FDA which we look forward to continuing through the ongoing review process.”
