AbbVie Submits Europe Application for Risankizumab for Crohn's Disease
November 30 2021 - 08:58AM
Dow Jones News
By Robb M. Stewart
AbbVie Inc. is seeking European regulatory approval for the use
of risankizumab to treat patients 16 years and older with moderate
to severe active Crohn's disease.
If approved by the European Medicines Agency, Crohn's disease
would mark the third indication for risankizumab in the European
Union, following plaque psoriasis and psoriatic arthritis.
AbbVie said Tuesday its submission in Europe is supported by
three pivotal Phase 3 studies in which risankizumab demonstrated
significant improvements in clinical remission and endoscopic
response as both induction and maintenance therapy. No new safety
risks were observed compared with the known safety profile of
risankizumab, the company said.
Crohn's disease is a chronic, systemic disease that manifests as
inflammation within the digestive tract, causing persistent
diarrhea and abdominal pain.
Risankizumab is part of a collaboration between Boehringer
Ingelheim GmbH, with AbbVie leading development and
commercialization globally.
Write to Robb M. Stewart at robb.stewart@wsj.com
(END) Dow Jones Newswires
November 30, 2021 08:43 ET (13:43 GMT)
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