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 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.