AbbVie Submits Regulatory Applications for Treatment of Ulcerative Colitis
September 16 2021 - 8:43AM
Dow Jones News
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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