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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