AbbVie announced on Monday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Rinvoq (upadacitinib). According to reports, 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.
Reportedly, the patients who were administered this drug have typically responded inadequately to nonsteroidal anti-inflammatory drugs. It is noteworthy that AbbVie’s application for the approval of Rinvoq is supported by results from the phase 3 SELECT-AXIS 2 study. The company disclosed the results of the study last year.
During the study, the therapy met the primary endpoints, while safety data were reported with no new risks identified compared to the known safety profile.
“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. 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, vice president, developed, and chief medical officer at AbbVie said.
Currently, Rinvoq approved for use in the EU in patients with moderate to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis.