The Biologics License Application (BLA) for teplizumab for the delay or prevention of type 1 diabetes (T1D) in at-risk individuals has been submitted to the Food and Drug Administration (FDA).

The BLA is supported by data from a phase 2 trial that evaluated whether teplizumab, an anti-CD3 monoclonal antibody, could prevent or delay the onset of T1D in at-risk individuals. Relatives of patients with T1D were randomized to receive intravenous infusions of either teplizumab (n=44) or placebo (n=36) for 14 consecutive days; oral glucose tolerance tests were used to assess progression to clinical T1D every 6 months. 

Findings from an extended follow-up showed that treatment with teplizumab significantly delayed progression to clinical T1D by a median of approximately 3 years compared with placebo in this patient population. Additionally, teplizumab treatment was reported to significantly reverse the decline in C-peptide levels. 

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Commenting on the submission, Ashleigh Palmer, CEO and Co-Founder, Provention Bio, said: “We look forward to continuing on our path toward changing the current treatment paradigm for T1D and, if approved, bringing teplizumab, designated by the FDA as a Breakthrough Therapy, to the US market in 2021.”

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  1. Provention Bio completes rolling submission of the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals. [press release]. Red Bank, NJ: Provention Bio, Inc; November 2, 2020. 
  2. Provention Bio’s teplizumab continued to significantly delay the onset of insulin-dependent type 1 diabetes (T1D) in presymptomatic patients. [press release]. Oldwick, NJ: Provention Bio, Inc; June 15, 2020.