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EMA's CHMP Recommends AbbVie's Upadacitinib For Ulcerative Colitis

BY Benzinga
— 7:01 AM ET 05/23/2022
  • The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approving AbbVie Inc's NYSE:ABBV upadacitinib (Rinvoq, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for ulcerative colitis.
  • The opinion covers the adult UC patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
  • Related: AbbVie's Upadacitinib Shows Clinical Response In Crohn's Disease Maintenance Study At One Year.
  • AbbVie's application for the approval of upadacitinib in UC is supported by data from two induction studies and one maintenance study.
  • Across all three Phase 3 studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission and all secondary endpoints. 
  • Price Action: ABBV shares closed lower by 0.13% at $150.73 on Friday.

More ABBV News

  • BRIEF-AbbVie Inc Says CHMP Recommends European Commission Approval Of Upadacitinib For Treatment Of Adults With Moderate To Severe Ulcerative Colitis
    Reuters - 2:05 AM ET 05/23/2022
  • CHMP Recommends European Commission Approval of Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderate to Severe Ulcerative Colitis
    PR Newswire - 2:00 AM ET 05/23/2022
  • CNBC's Final Trades: AbbVie, Costco Wholesale, Deere And This Kevin O'Leary Pick
    Benzinga - 4:22 PM ET 05/22/2022
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