Posted by Michael Wonder on 02 Jun 2021
Amryt announces FDA acceptance of new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa
2 June 2021 - Amryt today announces that the U.S. FDA has accepted for filing Amryt’s new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa.
The FDA has informed Amryt that notification of any filing review issues, including priority review determination and the Prescription Drug User Fee Act target action date for the NDA will be provided by 12 June 2021 (Day 74 post submission date).
The new drug application is supported by positive results from Amryt’s pivotal global Phase 3 trial EASE reported in September,2020.
