CHMP recommends European Commission approval of Rinvoq

Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients

AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

UC is the chronic inflammation of the large intestine, usually beginning in the rectum and lower colon, but may also spread continuously to involve the entire colon, which could lead to a significant burden and disability for patients. Living with UC impacts all aspects of a patient's life, largely due to unpredictable symptoms such as bowel urgency, abdominal pain, rectal bleeding and bowel incontinence.

"As leaders in the advancement of care for people with inflammatory bowel disease, we are committed to continued research and development of treatment options that go beyond managing symptoms and include endoscopic and histologic outcomes," said Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie. "With today's CHMP recommendation of upadacitinib in ulcerative colitis, we've taken a giant step forward toward helping more patients achieve their treatment goals."

AbbVie's application for the approval of upadacitinib in UC is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance. Across all three Phase 3 studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission and all secondary endpoints. This includes statistically significant improvements in these endpoints compared to placebo with 45 mg once daily for the induction studies, and with both 15 mg and 30 mg once-daily doses for the maintenance study.1-3 Additionally, safety results of upadacitinib in UC were consistent with the known safety profile of upadacitinib in rheumatoid arthritis, with no new important safety risks observed.1-3, 7-10

"Patients with ulcerative colitis often face numerous complications and risk relapse. Achieving critical endpoints like clinical remission and mucosal healing can make a significant difference in symptom management and health related quality of life," said Silvio Danese, M.D., Ph.D., director of Gastroenterology and Endoscopy at San Raffaele Hospital and professor of gastroenterology at University Vita-Salute San Raffaele, Milan, Italy. "Upadacitinib could be a promising option for adult patients who continue to have moderately to severely active disease despite treatment with conventional or biologic therapies and I look forward to the European Commission's final decision on its use in ulcerative colitis."