AbbVie files for Rinvoq ulcerative colitis indication in USA and EU

US drug major AbbVie (NYSE: ABBV) has submitted applications seeking approval for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis to the US Food and Drug Administration (FDA), and to the European Medicines Agency (EMA).

"Many people continue to struggle with symptoms associated with their ulcerative colitis, such as fatigue, bowel urgency, bloody diarrhea and abdominal pain," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie, adding: "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."

AbbVie generated global net revenues for Rinvoq from all existing indications in full year 2020 of $731 million, and $378 million in the second quarter of this year.