Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis

 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis

Dermavant Reports the First Patient Dosing in P-III ADORING Program of Tapinarof for the Treatment of Atopic Dermatitis

Shots:

  • The submission is based on P-III PSOARING 1 & PSOARING 2 data as well as interim results from PSOARING 3 long-term safety study evaluating the safety and efficacy of tapinarof vs vehicle in patients with plaque psoriasis
  • Results: Improvement in PGA scores of 0 or 1 with a minimum 2-grade improvement from baseline @12 wks., improvement in all 2EPs @ 12 wks., 40% of patients achieved complete disease clearance with continued therapy. Additionally, remittive benefit of 4 mos. was identified following treatment discontinuation
  • Tapinarof is a steroid-free, cosmetically elegant, topical cream for the treatment of PsO and AD

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