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Fibrocell's genetic skin disorder therapy gets US FDA fast-track status

Fibrocell Science Inc. said the U.S. Food and Drug Administration granted a fast-track designation to the company's drug, FCX-013, to treat a genetic skin disorder with no FDA-approved therapies.

FCX-013 is being developed as a potential therapy to treat moderate to severe localized scleroderma, a chronic autoimmune disorder that causes the body to produce too much collagen, resulting in the thickening of the skin and connective tissue.

Previously, the FDA granted an orphan drug designation to FCX-013 to treat localized scleroderma and rare pediatric disease designation for treating moderate to severe localized scleroderma.

The Exton, Pa.-based cell and gene therapy company is developing FCX-007 for treating recessive dystrophic epidermolysis bullosa, a severe skin condition characterized by repeated blistering of the skin, in a phase 1/2 clinical trial. The drug has also received orphan drug, rare pediatric disease and fast-track designations from the FDA.

Fibrocell is developing FCX-007 and FCX-013 in collaboration with Precigen Inc., a unit of Intrexon Corp., a Germantown, Md.-based biotechnology company.