CHMP returns positive opinion on Rinvoq for the treatment of adults with active non-radiographic axial spondyloarthritis
AbbVie has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Rinvoq (upadacitinib).
The once-daily treatment involves patients who have active non-radiographic axial spondyloarthritis (nr-asSpA) with objective signs of inflammation, as indicated by an elevated C-reactive protein and/or magnetic resonance imaging. The individuals have typically responded inadequately to nonsteroidal anti-inflammatory drugs.
AbbVie’s application for the approval of Rinvoq is supported by results from the phase 3 SELECT-AXIS 2 study, for which the company disclosed top line results in 2021. During the study the therapy met the primary endpoints, while safety data was reported with no new risks identified compared to the known safety profile.
The CHMP positive opinion is a scientific recommendation for marketing authorisation to the European Commission, which will review it and issue a commission decision that will be valid in all member states of the EU, as well as Iceland, Liechtenstein, Northern Ireland and Norway.
"Patients with axSpA often experience delayed diagnosis and once they do receive one, there are limited therapies available to help control disease symptoms, such as inflammation, back pain and stiffness,” explained Neil Gallagher, vice president, development and chief medical officer at AbbVie. "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."
Rinvoq 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.