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