BRIEF—Amryt submits to US FDA for Oleogel-S10 approval

Rare disease specialist Amryt Pharma has submitted a New Drug Application (NDA) to the US regulator for Oleogel-S10, to treat 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 NDA submission, which includes a request for Priority Review, comes days after the European regulator validated a Marketing Authorization Application (MAA) for the candidate in this indication.

If approved, Amryt plans to market the product under the brand name Filsuvez.