Provention Bio Inc.'s teplizumab, or PRV-031, was granted the priority-medicines designation by the European Medicines Agency.
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Teplizumab is being developed to either prevent or delay type 1 diabetes in people who are at risk of developing the disorder. Most often these people are completely unable to produce insulin, and Provention's medicine is designed to restore the function of certain cells in the pancreas that synthesize insulin and reduces the need for patients to get it from other means.
The PRIME designation, granted by the EMA's Committee for Medicinal Products for Human Use, is designed to expedite the development of medicines that target an unmet medical need and that may offer a major therapeutic advantage over existing treatments.
Previously, teplizumab received the U.S. Food and Drug Administration's breakthrough-therapy designation for the same indication.
The designations are based on a mid-stage study that showed the drug can delay the onset of type 1 diabetes by at least two years, both in adults and children.
Recently the Oldwick, N.J.-based pharmaceutical company secured $62.7 million via a public offering and a private placement primarily to finance U.S. regulatory submission for teplizumab.