Amryt announces FDA acceptance of NDA for Oleogel-S10 for the treatment of epidermolysis bullosa.

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. The FDA has informed Amryt that notification of any filing review issues, including priority review determination and the Prescription Drug User Fee Act (“PDUFA”) target action date for the NDA will be provided by June 12, 2021 (Day 74 post submission date). The NDA is supported by positive results from Amryt’s pivotal global Phase 3 trial in EB (“EASE”) reported in September, 2020. EASE was the largest ever global Phase III study conducted in patients with EB and is the first Phase III trial ever to demonstrate positive results in EB.