AbbVie Seeks Approval For Inflammatory Bowel Disease Candidate From U.S. FDA and European Medicines Agency

AbbVie ABBV has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Upadacitinib (RINVOQ) for the treatment of adult patients with moderately to severely active Crohn's disease.

The regulatory submissions are supported by data from three Phase 3 clinical trials, including two induction studies (U-EXCEED & U-EXCEL) and one maintenance study (U-ENDURE).

The safety results of Upadacitinib in U-EXCEED, U-EXCEL and U-ENDURE studies were generally consistent with the known safety profile of upadacitinib, with no new safety risks observed.

Neil Gallagher, Vice president and Chief medical officer, commented : "Crohn's disease can be debilitating and have a significant impact on a person's daily life. Those patients who are still suffering fuel our continued commitment to innovation in care for patients with IBD, and we look forward to potentially introducing a new treatment option for this disruptive condition.”

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.

Price Action : AbbVie shares are trading down at $149.88 on Wednesday at the time of publication.