FDA pushes back Provention diabetes drug review

July 1, 2022

NJ-based Provention Bio announced this week that the FDA has extended the review period for the Biologics License Application (BLA) for teplizumab by three months. 

Teplizumab is an antibody treatment for diabetes prevention and Provention’s leading investigational drug candidate. The drug targets the CD3 complex associated with the development of apoptosis, or cell death, and has shown value in preserving beta cells in the pancreas, reducing the need for insulin among Type 1 patients in trials.

Provention first filed an FDA marketing application for teplizumab back in January of 2021, but faced some roadblocks a few months later. In April of 2021, the FDA uncovered “deficiencies” in the marketing applications, prompting an Advisory Committee meeting to decide the fate of the application. The administration then granted the drug Breakthrough Therapy Designation.

The updated extended User Fee Goal date for the application is now November 17, 2022. In previous communications with the company, the FDA had stated that they consider a recent information request a major Amendment to the BLA resubmission, and so they will need more time to review the application.

"We are committed to collaborating closely with the Agency as it completes its review," said Ashleigh Palmer, Co-Founder and CEO of Provention Bio. "We want to thank the FDA for its continued diligence as we continue to work towards bringing this potential first disease modifying therapy to patients with type 1 diabetes in the United States, for whom there is currently no approved treatment other than a life-time of exogenous insulin therapy."