May 1, 2017
Duke researcher’s drug RVT-802 receives pioneering FDA regenerative medicine designation
RVT-802 is a biologic aimed at treating DiGeorge Syndrome, a fatal pediatric illness, and was invented by Dr. M. Louise Markert, Professor of Pediatrics at Duke University. The drug is currently held and being developed by Enzyvant, a subsidiary of Roivant Sciences. The drug has received both Breakthrough Therapy Designation as well as Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. RVT-802 is one of the first therapies to have received this RMAT designation.