Pharmaceutical company AbbVie (NYSE: ABBV) declared on Monday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of upadacitinib (RINVOQ, 45 mg [induction dose] and 15mg and 30mg [maintenance doses]), to treat adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

AbbVie said its application for the approval of upadacitinib in Crohn's disease is supported by data from two induction studies, U-EXCEED and U-EXCEL and one maintenance study, U-ENDURE.

Patients receiving upadacitinib were treated with 45mg once daily for the induction studies, and were randomized to receive either 15mg or 30mg once-daily doses for the maintenance study.

In all three studies, a statistically significant greater proportion of patients treated with upadacitinib achieved the key secondary endpoint of endoscopic remission and more upadacitinib-treated patients achieved SES-CD ulcerated surface subscore of 0 at weeks 12 and 52.

The company added that RINVOQ is approved in the EU for the treatment of 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.

In addition, the use of upadacitinib in Crohn's disease is approved in Great Britain as of January 2023. Its safety and efficacy remain under evaluation in the European Union.