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CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.
AbbVie announced on Feb. 27, 2023 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of RINVOQ (upadacitinib) for the treatment of Crohn’s disease. The indication would be as a 45-mg induction dose, followed by maintenance doses of 30 or 15 mg, in adult patients with moderate-to-severely active symptoms who have had an inadequate response, lost response, or who were intolerant to conventional therapy or a biologic agent.
Upadacitinib is a selective and reversible Janus kinase (JAK) inhibitor. According to a company press release, in human cellular assay, upadacitinib functions by preferentially inhibiting signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.
Data from two induction studies (U-EXCEED and U-EXCEL) and one maintenance study (U-ENDURE) was submitted in support of this indication. Across all three Phase III studies, patients treated with upadacitinib achieved the co-primary endpoints of clinical remission per stool frequency/abdominal pain and endoscopic response compared to placebo. Additional Phase III trials in Crohn’s disease, as well as trials treating giant cell arteritis and Takayasu arteritis, are ongoing.
"The recent CHMP recommendation to approve upadacitinib for use in Crohn's disease is a momentous step, bringing us closer to offering a first-of-its-kind, once-daily oral treatment that can make a difference for people living with this disease," said Roopal Thakkar, senior vice-president, Development, Regulatory Affairs, and chief medical officer, AbbVie. "We remain steadfast in our commitment to researching and developing treatment options as part of a diverse portfolio of therapies for those living with inflammatory bowel diseases."