BRIEF—EU to review Amryt's Filsuvez submission

Amryt has announced the validation of its Marketing Authorization Application (MAA) for Oleogel-S10 by the European Medicines Agency.

The firm has submitted for approval for the treatment of cutaneous manifestations of a rare skin disorder, junctional and dystrophic epidermolysis bullosa (EB).

The MAA is supported by data from the Phase III EASE study, which met its primary endpoint of accelerated healing of the target wound by day 45.

Chief executive Joe Wiley said: “The validation of the Oleogel-S10 MAA marks another important milestone for Amryt as we progress our lead development candidate Oleogel-S10 with the regulatory authorities in both Europe and the US.”

If approved, the company plans to use the brand name Filsuvez for the product.