Provention Bio's diabetes drug gains PRIME status; Avrobio earns orphan status
→ Two days after its J&J licensed Chron’s disease drug flunked a Phase IIa study, Provention Bio announced its lead drug, PRV-031 (teplizumab) for type-1 diabetes gained PRIME status from the EMA. Now in Phase III, the monoclonal antibody binds to the CD3 T Cell receptor with the aim of shutting down the self-reactive T cells responsible for type 1 diabetes without affecting the rest of the immune system. The drug is designed as a way of preventing or delaying the disease. It was originally licensed from MacroGenics.
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