Amryt Pharma said Filsuvez, a topical therapeutic gel, had demonstrated a significant increase in speed of wound healing in the rare disease Epidermolysis Bullosa (EB) in a late-stage trial, the first treatment to do so.
The British company said on Wednesday that U.S. regulatory submissions were already underway with the Food and Drug Administration (FDA), with a request planned for priority review, and EU regulatory submission was also planned with a request for accelerated assessment.
EB is a rare, chronic and distressing genetic skin disorder that causes the skin layers and internal body linings to separate and affects infants, children and adults.
(Reporting by Paul Sandle)
