Benzinga | Jun 2, 2021 08:38AM EDT

Amryt Announces FDA Acceptance Of New Drug Application For Oleogel-S10 For Treatment Of Epidermolysis Bullosa

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 accepted for filing 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.

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 3 study conducted in patients with EB and is the first Phase 3 trial ever to demonstrate positive results in EB.

Joe Wiley, CEO of Amryt Pharma, commented: "We are very pleased with the FDA's acceptance of our NDA for Oleogel-S10 as a potential treatment for EB and we look forward to continuing to work closely with the FDA throughout the review process. Today's news is also significant for patients. If approved, Oleogel-S10 could potentially be an important treatment option for those suffering from this devastating condition."