AbbVie today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of upadacitinib (RINVOQ® 15 mg, once daily) for the treatment of active non-radiographic axial spondyloarthritis (nr‑axSpA) in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).*
Patients with axSpA often experience delayed diagnosis and once they do receive a diagnosis, there are limited therapies available to help control disease symptoms, such as inflammation, back pain and stiffness. The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need.”
Neil Gallagher, M.D., Ph.D., Vice President, Development, Chief Medical Officer, AbbVie
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will review it and issue a Commission decision that will be valid in all member states of the European Union (EU), as well as Iceland, Liechtenstein, Northern Ireland and Norway.
AbbVie’s application for the approval of upadacitinib in nr-axSpA is supported by results from the Phase 3 SELECT-AXIS 2 study, for which AbbVie disclosed topline results in 2021. In the Phase 3 clinical study, the SELECT-AXIS 2 nr-axSpA study met the primary endpoint of Assessment of SpondyloArthritis international Society 40 percent response criteria (ASAS40), and the first 12 of 14 ranked secondary endpoints.1 Safety data were previously reported with no new risks identified compared to the known safety profile of upadacitinib.1
Upadacitinib is currently approved for use in the EU in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis.
The use of upadacitinib in nr-axSpA is not approved in the U.S. or EU. Its efficacy and safety remain under review.