The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AbbVie’s upadacitinib to treat adult patients suffering with moderately to severely active Crohn's disease.
Upadacitinib (RINVOQ, 45mg [induction dose] and 15mg and 30mg [maintenance doses]) is intended for those patients who have not shown adequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn’s disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract. It leads to persistent diarrhea and abdominal pain.
AbbVie senior vice president, development, regulatory affairs and chief medical officer Roopal Thakkar said: “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.”
The application filed by AbbVie for the approval of upadacitinib in Crohn’s disease is backed by data from two induction studies, named U-EXCEED and U-EXCEL, as well as one maintenance study, called U-ENDURE.
Patients receiving upadacitinib were treated with 45mg once daily for the induction studies, while for the maintenance study, patients were randomised to get either 15 mg or 30 mg once-daily doses.
It was found across all three Phase 3 studies that a significantly greater proportion of patients treated with upadacitinib met the co-primary endpoints of clinical remission per SF/AP (average daily stool frequency SF] ≤2.8 and abdominal pain [AP] score ≤1.0, with neither of these being more than baseline, while endoscopic response was >50% from baseline of the induction as against placebo.
Furthermore, in all three studies, a statistically greater proportion of patients treated with upadacitinib met the key secondary endpoint of endoscopic remission, which is termed as SES-CD ≤4 and at least a 2-point reduction vs. baseline and no subscore >1.
The safety profile of upadacitinib in Crohn’s disease was also generally in line with the known safety profile of upadacitinib.
RINVOQ is approved in the EU to treat adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, moderately to severely active ulcerative colitis and adults and adolescents with atopic dermatitis.
As of January this year, use of upadacitinib in Crohn’s disease is approved in Great Britain, while its safety and efficacy are under evaluation in the EU.
If the European Commission approves, this will be the seventh indication for upadacitinib in the EU and the first JAK inhibitor for Crohn’s disease.