AbbVie Submits Rinvoq to FDA and EMA for Ulcerative Colitis

AbbVie has submitted applications to the FDA and the EMA for Rinvoq (upadacitinib) for the treatment of adults with moderate-to-severe ulcerative colitis. The applications are supported by data from two phase 3 induction studies and one maintenance study.

In these studies, more patients treated with Rinvoq achieved the primary endpoint of clinical remission and all secondary end points compared with placebo with 45 mg once daily at week eight for the induction studies, and with 15 mg and 30 mg once daily at 52 weeks for the maintenance study.

The safety results of Rinvoq 15 mg or 30 mg were consistent with the safety profile observed in the phase 3 induction studies in ulcerative colitis, as well as in previous studies across indications. No new safety risks were identified.

“Many people continue to struggle with symptoms associated with their ulcerative colitis, such as fatigue, bowel urgency, bloody diarrhea and abdominal pain,” Tom Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie, said in a statement. "Upadacitinib has the potential to be an important new treatment option for people with ulcerative colitis, who want to address these challenging and disruptive symptoms. We look forward to working with regulatory authorities and hope to bring upadacitinib to people with ulcerative colitis as quickly as possible."

Ulcerative colitis is a chronic inflammatory bowel disease of the large intestine. In 2015, an estimated 1.3% of U.S. adults (3 million) reported being diagnosed with inflammatory bowel disease, either Crohn’s disease or ulcerative colitis, according to the CDC.

Rinvoq is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Rinvoq 15 mg is approved in the United States for adults with moderate to severe rheumatoid arthritis. It is approved in the EU for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis, adults with active ankylosing spondylitis (AS), and adults and adolescents 12 years and older with moderate to severe atopic dermatitis (AD). Rinvoq 30 mg is approved in the EU for adults with moderate to severe atopic dermatitis under age 65.

Related: FDA’s New Warning Includes Xeljanz and other JAK Inhibitors