Dermavant Reports the US FDA’s Acceptance of NDA for Tapinarof Cream to Treat Plaque Psoriasis

August 11, 2021 Auto Bot Acceptance, Clinical Trials, Dermavant, FDA, NDA, Plaque Psoriasis 0

Shots:

  • The NDA is based on P-III PSOARING 1 & 2 along with interim results from PSOARING 3 OLE study evaluating the safety & efficacy of tapinarof vs vehicle in patients with PsO
  • In PSOARING 1 & 2 results: patients achieved a PGA score of 0 or 1 (35.4% vs 6% & 40.2% vs 6.3%) & reached PASI 75 (36.1% vs 10.2% & 47.6% vs 6.9%) @12wks., 80% of patients achieved a ≥1-grade improvement in PGA in both studies respectively
  • The PSOARING 3 study showed that 57.3% of patients who entered the study with a PGA of ≥2 achieved a PGA score of 0 or 1 with the improvement in therapeutic effect beyond 12wks. & 39.2% achieved complete disease clearance. The anticipated PDUFA date is in Q2’22

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