Amryt Reports NDA Submission for Oleogel-S10 (filsuvez) to Treat Cutaneous Manifestations of Junctional and Dystrophic Epidermolysis Bullosa

 Amryt Reports NDA Submission for Oleogel-S10 (filsuvez) to Treat Cutaneous Manifestations of Junctional and Dystrophic Epidermolysis Bullosa

Amryt Reports NDA Submission for Oleogel-S10 (filsuvez) to Treat Cutaneous Manifestations of Junctional and Dystrophic Epidermolysis Bullosa

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

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Amryt Pharma

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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