Type 1 diabetes patients now have a new therapeutic option for the autoimmune disorder. Provention Bio drug Tzield has received FDA approval for delaying the onset of the most severe stage of this chronic disease.
Provention Bio needs to show the FDA that the drug substance produced from its contract manufacturer is comparable to the Eli Lilly-made drug substance that was evaluated in clinical trials. A larger study testing the prospective type 1 diabetes therapy teplizumab is ongoing and could provide the information the agency needs.
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