Recommended Approval for AbbVie’s Rinvoq Treatment
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has returned a positive opinion on Rinvoq. The Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) is a once-daily treatment for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine.
The drug was first approved for treating rheumatoid arthritis in 2019. In January 2022, it received FDA approval for spinal spondyloarthritis. Other indications have included psoriatic arthritis, atopic dermatitis and ulcerative colitis.
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With ankylosing spondylitis signs of inflammation are indicated by an elevated C-reactive protein. “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,” Neil Gallagher, Vice President, Development and Chief Medical Officer at AbbVie explained in an official press release.
The phase 3 SELECT-AXIS 2 study supported AbbVie’s application for approval of Rinvoq. The study recorded primary endpoint success, and no new risks were identified compared to its known safety profile.
The Janus kinase 1 inhibitor Rinvoq is a once-daily treatment for ankylosing spondylitis.
The CHMP’s scientific recommendation for marketing authorisation of Rinvoq is a promising move forward for the treatment of active non-radiographic axial spondyloarthritis. “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,” Gallagher confirmed.
Next steps will include the European Commission’s official review and decision, which will affect commission across all EU nationals as well as Iceland, Liechtenstein, Northern Ireland, and Norway.
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