EU approves Rinvoq in Crohn’s disease – AbbVie

AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

The EC approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study. Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with Rinvoq 45 mg in the induction studies and Rinvoq 15 mg and 30 mg in the maintenance study compared to placebo.

Co-Primary Endpoint Results from the Phase III program include: Endoscopic response: In U-EXCEED and U-EXCEL, 35% and 46% of patients treated with Rinvoq 45 mg achieved endoscopic response at week 12, respectively, compared to 4% and 13% of patients receiving placebo. In U-ENDURE, 28% and 40% of patients treated with Rinvoq 15 mg and 30 mg achieved endoscopic response at week 52, respectively, compared to 7% of patients receiving placebo.

Clinical remission: In U-EXCEED and U-EXCEL, 40% and 51% of patients treated with Rinvoq 45 mg achieved clinical remission at 12 weeks, respectively, compared to 14% and 22% of patients receiving placebo. Additionally, in U-ENDURE, 36% and 46% patients treated with Rinvoq 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.