Shots:

• The NDA is based on the P-III EASE trial involves assessing Oleogel-S10 (filsuvez) vs control gel in patients with EB. The study met its 1EPs of accelerated healing of the target wound @ day 45
• The NDA request for Priority Review to expedite the review process of 6 mos.- following acceptance of the NDA submission. The company also reported that EMA has begun the validation of MAA for the therapy
• Oleogel-S10 has received OD- FTD- and Pediatric Rare Disease designation from FDA previously

  Ref: GlobeNewswire | Image: Amryt Pharma