Incyte’s Opzelura (ruxolitinib) Receives the US FDA’s Approval for the Treatment of Atopic Dermatitis

September 22, 2021 Auto Bot approval, Atopic Dermatitis, FDA, Incyte, Opzelura, regulatory 0

Shots:

  • The approval is based on the TRuE-AD clinical trial program which consists of two P-III studies i.e., TRuE-AD1 & 2 evaluating the safety and efficacy of Opzelura cream (1.5%, bid) vs vehicle (non-medicated cream) in 1200+ adolescents & adults aged ≥12yrs. with mild to moderate AD
  • The results showed that the patients achieved IGA-TS @8wks. (53.8% & 51.3% vs 15.1% & 7.6%) & clearer skin, reduction in itch from baseline @8wks. as measured by a ≥4-point reduction in the itch NRS4 (52.2% & 50.7% vs 15.4% & 16.3%) respectively
  • Opzelura is the first topical formulation of a JAK inhibitor approved in the US. The therapy is currently being evaluated is in the P-III TRuE-V clinical program for the treatment of vitiligo

Click here to­ read full press release/ article | Ref: Businesswire | Image: Reuters

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