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

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

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

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

  | Ref: Businesswire | Image: Businesswire

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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