FDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa
PDUFA date of
DUBLIN, Ireland, and
Boston MA,
June 3, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the U.S. Food and Drug Administration (“FDA”) has granted Priority Review for Amryt’s New Drug Application (“NDA”) for Oleogel-S10 for the treatment of Epidermolysis Bullosa (“EB”). Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.