European Commission approves Rinvoq for moderate to severe UC
The European Commission approved Rinvoq for the treatment of patients with moderate to severe ulcerative colitis who had an inadequate response, lost response or were intolerant to conventional therapy, according to an AbbVie press release.
Approval of Rinvoq (upadacitinib, AbbVie) was based on results from three phase 3 studies, in which the primary endpoint of clinical remission was achieved at week 8 in two induction studies (45 mg upadacitinib, U-ACHIEVE and U-ACCCOMPLISH) and at week 52 in the U-ACHIEVE maintenance study (15 mg and 30 mg). Rinvoq also induced secondary endpoints of clinical response and mucosal healing, with no new important safety risks reported, the company stated.
“Our years of experience and long-term investment in inflammatory bowel disease research have given us invaluable insights into the challenges that ulcerative colitis patients face and a deep understanding of the ongoing need for additional treatment options to help those still suffering,” Thomas Hudson, MD, senior vice president of research and development and chief scientific officer at AbbVie, said in the release. “We celebrate today’s approval of Rinvoq by the [European Commission] as it meaningfully expands our ability to help indicated patients in need of relief from ulcerative colitis.”
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