Posted by Michael Wonder on 28 Feb 2022
Amryt receives complete response letter from the FDA for Oleogel-S10 NDA
28 February 2022 - Amryt receives complete response letter from the FDA for Oleogel-S10 NDA.
Amryt today announced it has received a complete response letter from the US FDA regarding its new drug application for Oleogel-S10, for the treatment of the cutaneous manifestations of dystrophic and junctional epidermolysis bullosa, a rare, genetic skin disease characterised by extremely fragile skin that blisters and tears from minor friction or trauma for which there are no approved treatment options.
The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in epidermolysis bullosa.
