Some good news for EB research – Amryt announces positive top line results from pivotal Phase 3 ‘EASE’ trial of FILSUVEZ® in epidermolysis bullosa. Ireland was among the locations where the study was performed. There is still a long way to go to get to market but really positive news coming from the world of research. We’ll have more information on the website as we receive it.
– Primary endpoint met with statistical significance (p-value = 0.013)
– FILSUVEZ® demonstrated a good safety profile
– EASE is the first Phase 3 trial to demonstrate a statistically significant increase in speed of wound healing in Epidermolysis Bullosa
– Rolling US regulatory submissions already underway with FDA with priority review request planned
– EU regulatory submission planned with request for accelerated assessment
– FILSUVEZ®, a topical therapeutic gel, has the potential to be the first treatment approved for Epidermolysis Bullosa
Read the full press release here