5 January 2017 - Fibrocell Science today announced that the U. S. FDA has granted fast track designation to FCX-007, the Company’s clinical-stage candidate for the treatment of recessive dystrophic epidermolysis bullosa; a rare, devastating genetic skin disease for which no FDA-approved therapies exist.
FCX-007 was previously granted orphan designation by the FDA for the treatment of dystrophic epidermolysis bullosa, which includes recessive dystrophic epidermolysis bullosa and rare paediatric disease designation by the FDA for treatment of recessive dystrophic epidermolysis bullosa.
Fibrocell is developing FCX-007 in collaboration with Intrexon Corporation.