Pittsburgh-based Krystal Biotech Inc. said the U.S. Food and Drug Administration granted the fast-track designation to KB103, a gene therapy for a certain skin disease.
KB103 is a topically applied herpes simplex virus-based gene therapy for treating dystrophic epidermolysis bullosa, a skin blistering condition caused by a lack of collagen. The therapy works by delivering a human collagen protein to those with the disease.
The regulator grants the designation to speed up the review of drugs that address serious conditions and fill an unmet medical need.
KB103 has also received the orphan drug designation from the U.S. FDA and the European Medicines Agency.
