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

Shots:

  • The submission is based on data from the P-III PSOARING 1 & PSOARING as well as interim results from PSOARING 3 long-term safety study 2 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 PsO and AD while the company has submitted NDA to FDA on May 26, 2021

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