AbbVie announced that the EMA CHMP recommended approval of RINVOQ® (upadacitinib) for treatment of moderate to severe Chron’s disease when patients have not responded to conventional therapy or biologic. The CHMP relied on three phase III trials, including two induction studies, U-EXCEED and U-EXCEL, and one maintenance study, U-ENDURE.
The CHMP recommend expanding the indications for RINVOQ® (upadacitinib) to treatment of moderate to severe atopic dermatitis (in addition to rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis) on 24 June 2021. On 19 May 2022, CHMP recommended it be further expanded to include moderate to severe active ulcerative colitis.