Amryt files MAA at EMA for Oleogel-S10 a treatment of cutaneous manifestations of junctional and dystrophic epidermolysis bullosa .

Amryt announces the validation of the Company’s Marketing Authorization Application (“MAA”) for Oleogel-S10 by the European Medicines Agency (“EMA”) for the potential treatment of cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”). EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. The EMA validation confirms that the application is sufficiently complete to begin the formal review process. The EMA review for Oleogel-S10 will be according to standard timelines with an opinion of the Committee for Medicinal Products for Human Use (“CHMP”) expected within 210 ‘active’ days (excluding any ‘clock-stops’ for the applicant to provide answers to questions from the CHMP). The MAA is supported by data from the EASE pivotal phase III trial in EB (“EASE”). Amryt announced in October 2020 that the EASE study met its primary endpoint of accelerated healing of the target wound by day 45 in patients treated with Oleogel-S10 vs the control gel.