AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Atopic Dermatitis

October 20, 2020 Auto Bot AbbVie, Atopic Dermatitis, regulatory, Rinvoq, Upadacitinib 0

Shots:

  • The company submitted applications to the US FDA & EMA seeking approval for Rinvoq (upadacitinib) for adults (15mg/30mg, qd) and adolescents (15mg, qd) with moderate to severe AD. The submission is based on three pivotal P-III studies and was studied without TCS in Measure Up 1 and Measure Up 2 and with TCS in AD Up
  • Results: Rinvoq demonstrated an improvement in skin clearance and reduction in itch in adults and adolescents, met its co-1EPs including at least a 75% improvement in EASI 75 and a validated (vIGA-AD) score of 0/1 @16wks., no new safety profile in observed
  • Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. The submissions reinforce AbbVie’s commitment to bringing Rinvoq to more patients living with immune-mediated diseases

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: The Wall Street Journal

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