Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, announced today that the U.S. Food and Drug Administration (FDA) posted briefing documents for the May 27, 2021 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the Biologics License Application (BLA) for teplizumab, Provention Bio’s investigational drug candidate for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
The Advisory Committee meeting is scheduled for 9:00 a.m. EST on Thursday, May 27. The briefing materials and the meeting can be accessed at: https://investors.proventionbio.com/events. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.
“We would like to recognize the FDA for their ongoing efforts in the review of the BLA for teplizumab and for convening this Advisory Committee meeting of key endocrinology leaders to discuss the potential merits of teplizumab as the first ever disease modifying therapy for T1D,” stated Ashleigh Palmer, Provention Bio’s CEO. “Additionally, we want to thank all of those throughout the T1D community, who have played a critical role in advancing T1D research and development, through clinical trial participation, advocacy efforts, screening, as well as making their voices heard throughout the process. It is your endless passion and tenacity towards seeking better solutions that has brought us this far, and together we will strive forward working to seek advancements for the lives of patients with T1D.”
On January 4, 2021, Provention Bio announced the FDA filing of the BLA and Priority Review for teplizumab for the delay of clinical T1D in at-risk individuals. Teplizumab has been granted Breakthrough Therapy Designation. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the BLA of July 2, 2021.
The BLA was filed on the pivotal TN-10 Study data that found a single 14-day course of teplizumab delayed clinical disease and insulin-dependence by at least two years in presymptomatic patients with Stage 2 T1D, compared to placebo. Teplizumab was generally well tolerated and the safety data from TN-10 are consistent with previous analyses. The main risks are mechanism-based, transient and predictable including lymphopenia, transaminase elevations, rash and cytokine release events; we believe these events are short-lived and manageable because teplizumab is given as a one course regimen and not chronically.
About Teplizumab (PRV-031):
Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) with a filed BLA under Priority Review by the FDA for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. 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 consistently demonstrated the ability to preserve beta-cell function as shown by C-peptide, a measure of endogenous insulin production. It correspondingly reduced the need for exogenous insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the FDA and PRIME designation by the European Medicines Administration. Provention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT study).
About Provention Bio, Inc.:
Provention Bio, Inc. is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The BLA for teplizumab, its lead investigational drug candidate, for the delay of clinical T1D in at-risk individuals has been filed by the FDA. The Company’s pipeline includes additional clinical-stage product 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. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.
Internet Posting of Information:
Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company’s website in the “News” section. Accordingly, investors should monitor this portion of the Company’s website, in addition to following its press releases, SEC filings and public conference calls and webcasts.