PRVB - Provention Bio completes U.S. application for diabetes prevention med

Provention Bio (PRVB) has completed its rolling U.S. marketing application for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk people, a Breakthrough Therapy-tagged indication. The company has requested Priority Review which, if granted, will shorten the review to six months.If all goes well, market launch will commence in 2021.Teplizumab is a CD3-targeted monoclonal antibody designed to slow the loss of insulin-producing beta cells in the pancreas while preserving beta cell function as measured by C-peptide.

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Provention Bio completes U.S. application for diabetes prevention med