AbbVie said Monday that the European Commission approved Rinvoq (upadacitinib) as the first oral JAK inhibitor for the treatment of adults 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. The drug is also under review in the US in this indication.
The European approval is supported by data from the two induction studies, U-EXCEED and U-EXCEL, along with the U-ENDURE maintenance trial. AbbVie noted that statistical significance was achieved for the co-primary endpoints and key secondary goals with Rinvoq 45mg in the induction studies and doses of 15mg and 30mg in the maintenance trial, compared to placebo.
"The [EU] approval of Rinvoq in Crohn's disease is a significant milestone in offering patients the first and only once-daily oral treatment that can provide endoscopic improvement, and sustained symptom relief," remarked Thomas Hudson, AbbVie's chief scientific officer. Rinvoq's first authorisation in Crohn's disease came in February in the UK.
Rinvoq is also authorised in the EU for the treatment of adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and for adults and adolescents with atopic dermatitis
