Posted by Michael Wonder on 18 Jun 2017
Fibrocell receives rare paediatric disease designation from FDA for FCX-013 for treatment of localised scleroderma
12 June 2017 - Gene therapy candidate under control of RheoSwitch therapeutic system technology is potential first-in-class treatment for chronic disease with high unmet need.
Fibrocell Science today announced that the U.S. FDA has granted rare paediatric disease designation to FCX-013, Fibrocell’s gene therapy candidate for the treatment of moderate to severe localised scleroderma—a chronic autoimmune disease characterized by thickening of the skin and connective tissue.
The rare paediatric disease designation augments the orphan drug designation previously granted by the FDA to FCX-013 for the treatment of localised scleroderma, which includes linear scleroderma.
