27 June 2022 - CHMP positive opinion is based on results from the Phase 3 SELECT-AXIS 2 study showing upadacitinib (RINVOQ®) met the primary endpoint of ASAS40 response at week 14 versus placebo.
AbbVie today announced the EMA CHMP recommended the approval of upadacitinib (Rinvoq 15 mg once daily) for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging, who have responded inadequately to non-steroidal anti-inflammatory drugs.