AbbVie Announces U.S. FDA Approval for RINVOQ® (upadacitinib)
Thursday, May 18, 2023
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers.
Based on the clinical trial results, treatment with RINVOQ shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation.
The 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.
RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
Crohn's disease need more treatment options that can help quickly relieve symptoms and visibly reduce damage to the intestinal lining. RINVOQ may provide this relief and is now available to treat Crohn's disease.
