AbbVie gains positive CHMP opinion for upadacitinib for the treatment of Crohn’s disease
AbbVie has announced that it has received positive feedback from the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (Rinvoq) for the treatment of adult patients with moderate to severe Crohn’s disease who have had an inadequate response, lost response or were intolerant to conventional therapies or biologic agents.
The drug’s approval follows data from two induction studies, U-EXCEED and U-EXCEL, as well as a maintenance study, U-ENDURE. Patients were treated with 45mg once daily for the induction trials and either 15mg or 30mg once daily in the maintenance study.
All three phase 3 studies showed a significantly greater proportion of patients treated with upadacitinib achieving primary endpoints of clinical remission per SF/AP (stool frequency [SF] <2.8 and abdominal pain [AP] score <1.0) and endoscopic response, when compared to the placebo groups.
Roopal Thakkar MD, senior vice president, development, regulatory affairs and chief medical officer at AbbVie, commented: “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. 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.”
Jean-Frédéric Colombel MD, professor of medicine and director of Inflammatory Bowel Disease Center, Icahn School of Medicine, Mount Sinai and study investigator, added: “The impact of Crohn’s disease extends beyond the gut to include systemic symptoms such as fatigue, bowel symptoms and social and emotional functioning. Treatment options that achieve critical endpoints such as clinical remission and endoscopic response can make a difference in managing the challenging symptoms of this condition and health-related outcomes related to quality of life. Upadacitinib could be a promising treatment option for patients who live with uncontrolled moderate to severe Crohn’s disease. I look forward to the European Commission’s final decision.”