1 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. The approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study. "We're pleased that RINVOQ may provide this relief and is now available to treat Crohn's disease."Įndoscopic Response and Clinical Remission "AbbVie recognizes the need for more treatment options for Crohn's disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage," said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. 1Īccess the multimedia news release here: 1 This is the seventh FDA approval for RINVOQ across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease. 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. NORTH CHICAGO, Ill., /PRNewswire/ - AbbVie (NYSE: ABBV) today announced that the U.S.
– This indication marks the seventh FDA approval for RINVOQ across gastroenterology, rheumatology and dermatology 1 – Clinical response was achieved by significantly more patients treated with RINVOQ (upadacitinib) versus placebo as early as week 2 in induction studies 1 – The co-primary endpoints of endoscopic response (visible reduction of intestinal lining damage) and clinical remission were achieved by significantly more patients treated with RINVOQ (upadacitinib) at week 12 and week 52 versus placebo 1
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