Update: Diamyd Medical’s CEO clarifies comments on the recent approval by FDA of Provention Bio´s drug candidate Teplizumab
This updated press release describes teplizumab according to the approved FDA label. Updates in italics.“The FDA approval of teplizumab is great news for the entire autoimmune diabetes field,” comments Ulf Hannelius, CEO of Diamyd Medical. “The approval creates clarity around the regulatory pathway for disease-modifying therapies in Type 1 Diabetes and will set a reference for the field regarding pricing and reimbursement. This is important and valuable for the antigen-specific immunotherapy Diamyd[®], the first ever precision medicine therapeutic for Type 1 Diabetes in Phase 3 development.“