The Food and Drug Administration (FDA) accepted Amrty’s application for Oleogel-S10 to be approved as a treatment for cutaneous manifestations of junctional and dystrophic EB, which affects adults and young children and for which there is no currently approved treatment.
Any potential filing review issues, including priority review determination and the Prescription Drug User Fee Act target action date for the application will be provided by June 12, the FDA said.
Amryt made the application on the back of Oleogel-S10 showing positive results in a pivotal global Phase 3 trial in EB, reported last September, which was the largest ever such study conducted in patients with EB and was the first ever to demonstrate positive results.
“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,” said Amryt chief executive Joe Wiley.
“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.”