Application is submitted to the FDA for approval of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis

The submission is based on results from the Phase III QUASAR program evaluating the efficacy and safety of Tremfya in the treatment of individuals living with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics and/or JAK inhibitors. The data show statistically significant and clinically meaningful improvements in symptoms, patient reported outcomes such as fatigue and measures of disease activity including high bar endpoints such as endoscopic and histologic remission The safety results were consistent with the known safety profile of Tremfya in approved indications.

“Despite advances in therapy, many people living with ulcerative colitis still experience inadequate response to or do not tolerate existing therapies,” said David Lee, MD, PhD, Global Therapeutic Area Head Immunology. Tremfya has the potential to be a new treatment option for patients. We look forward to working with the FDA in review of this application and remain focused on developing new therapies for those living with chronic autoimmune conditions, such as ulcerative colitis, who are experiencing persistent and debilitating symptoms.”