Posted by Michael Wonder on 29 Mar 2021
Amryt announces validation of its MAA by the EMA for Oleogel-S10 (Filsuvez)
29 March 2021 - Amryt today announces the validation of the Company’s marketing authorisation application for Oleogel-S10 by the EMA for the potential treatment of cutaneous manifestations of junctional and dystrophic epidermolysis bullosa.
The application is supported by data from the EASE pivotal Phase 3 trial in epidermolysis bullosa. 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.
