Provention Files Application, Priority Review for Teplizumab for Delay, Prevention of Type 1 Diabetes

 Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA). The FDA also granted Provention's request for Priority Review and assigned a user fee goal date of July 2, 2021, under the Prescription Drug User-Fee Act (PDUFA).

"The FDA's acceptance of our BLA represents a significant achievement for Provention Bio in our mission to deliver the first potential disease-modifying T1D therapy and drive a paradigm shift in how individuals at risk of developing the disease are treated," stated Ashleigh Palmer, CEO and Co-Founder, Provention Bio. "We intend to work closely with the FDA to support their review while also preparing for a potential product launch in the third quarter of 2021."

In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting, tentatively scheduled for May 27, 2021.

https://www.prnewswire.com/news-releases/provention-bio-announces-us-fda-filing-of-a-biologics-license-application-bla-and-priority-review-for-teplizumab-for-the-delay-or-prevention-of-clinical-type-1-diabetes-in-at-risk-individuals-301199992.html