re: PRVB
Provention Bio Files Clinical Module for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals
Wed, September 30, 2020, 1:05 PM PDT
- Expect to complete filing of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 -
RED BANK, N.J., Sept. 30, 2020 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the submission of the clinical module of the Company's Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab (PRV-031), an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical Type 1 Diabetes (T1D) in at-risk individuals.
A rolling submission allows for completed modules of the BLA to be submitted to the FDA on an ongoing basis. Provention initiated the rolling submission with the filing of the non-clinical module in April 2020. The Company expects to submit the final modules including the chemistry, manufacturing and controls (CMC) module in Q4 2020. Once the complete BLA has been submitted, the FDA will have 60 days to review the submission to determine if it is complete. If deemed complete, the application will be considered acceptable for review and the FDA will set a PDUFA goal date.
"The filing of the BLA clinical module for teplizumab is a critical step in our efforts to deliver teplizumab to pre-symptomatic patients to delay or prevent insulin-dependent T1D," said Dr. Eleanor (Leni) Ramos, MD, CMO, Provention Bio. "I especially want to thank Dr. Sharon Rowland, our SVP and Head of Regulatory Affairs and the BLA clinical team who have worked tirelessly for many months to achieve this goal. We look forward to working closely with the FDA as we advance the regulatory process and we remain on track to complete the full BLA submission in Q4 2020. In addition, we continue to scale our organization in preparation for a potential commercial launch, and we are well-positioned to execute our strategy to bring this disease-modifying treatment to the T1D community as soon as possible."
About Teplizumab (PRV-031):
Teplizumab is an anti-CD3 monoclonal antibody (mAb) being developed for the interception, delay, or prevention of type 1 diabetes (T1D). More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, teplizumab has consistently demonstrated the ability to preserve beta-cell function, a measure of endogenous insulin production, and correspondingly reduce the need for exogenous insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Administration. Provention Bio has initiated a rolling submission of the Biologic License Application for teplizumab for the delay or prevention of insulin-dependent T1D for use in presymptomatic patients and expects to complete the submission in Q4 2020. Provention is currently evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT Study).
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company leveraging a transformational drug development strategy focused on the prevention or interception of immune-mediated disease. Provention's mission is to source, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune diseases. Provention's diversified portfolio includes teplizumab, a clinical-stage candidate that has been shown in a clinical study to delay the onset of insulin-dependent type 1 diabetes (T1D) in at-risk patients during the presymptomatic phase of the disease as compared to placebo. The Company's portfolio includes additional clinical product development candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus.
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