AP101 will be launched commercially as FILSUVEZ.
“This, alongside our recent completion of recruitment into the EASE study, represents further progress as we endeavour to develop a therapy for patients with EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment," Amryt chief executive, Dr Joe Wiley said in a statement.
The top-line read-out from phase III EASE clinical trial is expected towards the end of the third quarter, or early Q4, Amryt has previously guided.
EB is a painful condition where skin blisters at the slightest touch. As there is currently no approved treatment, FILSUVEZ has fast-track status with the US regulatory authorities.
The company estimates the potential US and European market for FILSUVEZ to be worth in excess of US$1bn.