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

• 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.

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