AbbVie Submits Applications For New Indication To FDA And EMA For Ulcerative Colitis

(RTTNews) - Biopharmaceutical company AbbVie, Inc. (ABBV) announced Monday that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for risankizumab (SKYRIZI, 1200 mg intravenous [IV] [induction dose] as well as 180 mg and 360 mg subcutaneous [SC] [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis.

The Applications to the FDA and EMA are supported by data from two Phase 3 clinical trials: an induction study, INSPIRE, and a maintenance study, COMMAND. Significantly more patients treated with risankizumab 1200 mg IV at week 12 in the induction study and 180 mg or 360 mg SC at week 52 in the maintenance study achieved the primary endpoint of clinical remission, compared to patients receiving placebo.

Additionally, more risankizumab-treated patients in both the induction and maintenance studies achieved the key secondary endpoints of endoscopic improvement and histologic endoscopic mucosal improvement (HEMI) compared to placebo.

Risankizumab (SKYRIZI) is part of collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.