PRVB - FDA Advisory Committee supports Provention Bio's teplizumab in delaying diabetes

Provention Bio (PRVB) announces that the FDA's advisory committee voted 10-7, confirming that the benefits of PRVB's drug candidate teplizumab in delaying clinical type 1 diabetes (T1D) outweigh the risks. The recommendation is based on safety and efficacy data from TN-10 Study in which a single 14-day course of teplizumab delayed insulin-dependent, clinical-stage disease by a median of at least two years in presymptomatic patients with Stage 2 type 1 diabetes compared to placebo.The Committee Members discussed the strengths and limitations of the clinical data and provided opinions on the proposed indication statement and potential post-marketing studies. The FDA granted Breakthrough Therapy designation to teplizumab and priority review designation for the Biologics License Application ((BLA)), with PDUFA action date of July 2, 2021.The Agency will consider today's vote as it reviews the BLA.Shares of PRVB were halted yesterday.PRVB stock rallied 39% over the past week, mostly since May 25 after the FDA report on teplizumab.

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FDA Advisory Committee supports Provention Bio's teplizumab in delaying diabetes