AbbVie Receives European Commission Approval for Crohn’s Disease Therapeutic

AbbVie announced on April 17, 2023 that the European Commission (EC) has approved RINVOQ (upadacitinib), an oral Janus kinase (JAK) inhibitor, for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lose response, or were intolerant to either conventional therapy or a biologic agent.

Crohn’s disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract. It is progressive, potentially producing complications that require urgent medical care. According to a company press release, a significantly higher proportion of patients treated with RINVOQ achieved the co-primary endpoints of endoscopic response and clinical remission and the key secondary endpoint of corticosteroid-free clinical remission at weeks 12 and 52 compared to placebo.

"Crohn's disease is a burden that can present patients with daily, often uncomfortable challenges," said Laurent Peyrin-Biroulet, professor of gastroenterology and head of the inflammatory bowel disease group at the gastroenterology department, University Hospital of Nancy, France, in the press release. "These studies demonstrated RINVOQ's ability to achieve key treatment targets, including endoscopic outcomes and symptomatic relief, that are critical for patients and beneficial for long-term care."