Pharma Focus Asia

AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®)

Monday, February 27, 2023

AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of upadacitinib (RINVOQ®, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active Crohn's disease containing inadequate response, lost response or intolerant to either conventional therapy or a biologic agent.

The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance study. If approved by the European Commission (EC), upadacitinib will be the seventh indication in the European Union (EU), and the first JAK inhibitor for Crohn's disease, adding to AbbVie's gastroenterology portfolio.

RINVOQ is approved in the EU for the treatment of adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, moderately to severely active ulcerative colitis and adults and adolescents with atopic dermatitis.

Upadacitinib (RINVOQ) discovered and developed by AbbVie scientists, is a selective and reversible Janus Kinase (JAK) inhibitor. In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. Upadacitinib will become a promising treatment option for patients living with uncontrolled moderate to severe Crohn's disease.

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