AbbVie Receives Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis marketscreener.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from marketscreener.com Daily Mail and Mail on Sunday newspapers.
Reports Third-Quarter Diluted EPS of $1.00 on a GAAP Basis, a Decrease of 54.8 Percent; Adjusted Diluted EPS of $2.95, a Decrease of 19.4 Percent; These.
Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission and key secondary endpoints as an induction and maintenance.
AbbVie Inc. announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration and European Medicines Agency for risankizumab for the treatment of adult.
AbbVie has submitted a regulatory application to the FDA seeking approval of risankizumab for the treatment of adults with moderately to severely active ulcerative colitis.