FDA Clears AbbVie's Rinvoq For Moderate To Severe Active Ulcerative Colitis

• The FDA approved AbbVie Inc's (NYSE:ABBV) Rinvoq (upadacitinib) for adults patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blockers. 
• This FDA approval is the first indication for Rinvoq in gastroenterology and is supported by efficacy and safety data from three Phase 3 clinical studies.
• Across all clinical trials, significantly more patients treated with Rinvoq achieved clinical remission at weeks 8 and 52, the primary endpoint, compared to placebo. 
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• In addition, the studies met all ranked secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), as well as corticosteroid-free clinical remission in the maintenance study. 
• Price Action: ABBV shares are up 0.01% at $156.06 during the premarket session on the last check Thursday.