ABBV AbbVie Inc

By Dave Sebastian

AbbVie Inc. said it has submitted applications seeking approval for upadacitinib, a candidate for treating adults with moderately to severely active ulcerative colitis, to the U.S. Food and Drug Administration and the European Medicines Agency.

The company on Thursday said the applications are supported from two Phase 3 induction studies and one maintenance study. More patients treated with the drug candidate reached the primary endpoint of clinical remission and all secondary endpoints compared with a placebo, it said.

Ulcerative colitis is a type of inflammatory bowel disease of the large intestine. Symptoms include rectal bleeding, abdominal pain and bloody diarrhea.

Write to Dave Sebastian at dave.sebastian@wsj.com

(END) Dow Jones Newswires

September 16, 2021 08:28 ET (12:28 GMT)

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