• 29 Jun 2022
• Admin
• News Article

EMA committee recommends approval of AbbVie upadacitinib to treat active non-radiographic axial spondyloarthritis

AbbVie 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," said Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, 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." 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. Safety data were previously reported with no new risks identified compared to the known safety profile of upadacitinib. 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 US or EU. Its efficacy and safety remain under review. SELECT-AXIS 2 (NCT04169373) was conducted under a master protocol and includes two separate studies (SELECT-AXIS 2 AS (bDMARD-IR) study, or Study 1 and SELECT-AXIS 2 nr-axSpA study, or Study 2). Study 1: SELECT-AXIS 2 AS (bDMARD-IR) study: -- A randomized, double-blind, placebo-controlled phase 3 trial, which evaluated the efficacy and safety of upadacitinib compared with placebo, in 420 patients with a clinical diagnosis of AS who fulfilled the modified New York criteria, had BASDAI score =4 and total back pain score =4 (based on a numerical scale of 0-10), and had an inadequate response to bDMARD therapy. Study 2: SELECT-AXIS 2 nr-axSpA study: -- A randomized, double-blind, placebo-controlled, phase 3 trial which evaluated the efficacy and safety of upadacitinib compared with placebo, in 314 patients with a clinical diagnosis of nr-axSpA. Patients enrolled in the study had active signs of inflammation as indicated by MRI + sacroiliac joint inflammation, and/or high sensitivity C-reactive protein (hs-CRP) >upper limit of normal (2.87 mg/L) at screening, and who had BASDAI score =4 and a total back pain score =4 (based on a numerical scale of 0-10). Axial spondyloarthritis is a chronic inflammatory disease that affects the spine, causing back pain, limited mobility, and structural damage. It consists of two subsets that have been clinically defined as radiographic axial SpA (ankylosing spondylitis) and non-radiographic axial spondyloarthritis (nr-axSpA). In ankylosing spondylitis, patients have definitive structural damage of the sacroiliac joints visible on X-rays. Non-radiographic axial spondyloarthritis is clinically defined by the absence of definitive X-ray evidence of structural damage to the sacroiliac joint by plain X-ray. Discovered and developed by AbbVie scientists, Rinvoq is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, Rinvoq preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK. In the EU, Rinvoq is approved for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy; and for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. Phase 3 trials of Rinvoq in axial spondyloarthritis, Crohn's disease, giant cell arteritis and Takayasu arteritis are ongoing. Use of Rinvoq in nr-axSpA is not approved and remains under review by regulatory authorities. For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.