AbbVie Submits Regulatory Application to FDA for Rinvoq for Ankylosing Spondylitis

AbbVie has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for Rinvoq™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis. AbbVie also submitted an application to the European Medicines Agency (EMA) for RINVOQ earlier this year for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.

"Ankylosing spondylitis is a debilitating disease that can cause severe pain, restricted mobility and lasting structural damage. With limited treatment options, innovation is crucial to help more patients living with active ankylosing spondylitis reach their treatment goals," said Michael Severino, M.D., vice chairman and president, AbbVie. "Rinvoq has the potential to improve care by helping to provide disease control, addressing pain and improving function. We look forward to working with regulatory authorities and hope to bring this important treatment option to patients."

The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.1 In this study, twice as many patients receiving Rinvoq (52 percent) met the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response versus placebo (26 percent) at week 14 (p<0.001). The safety profile of Rinvoq in ankylosing spondylitis was consistent with previously reported studies across therapeutic areas, including rheumatoid arthritis, atopic dermatitis and psoriatic arthritis, with no new significant safety risks detected.

Ankylosing spondylitis is a chronic, progressive, inflammatory musculoskeletal disease impacting more than five million people worldwide. The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.

Discovered and developed by AbbVie scientists, Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In August 2019, Rinvoq received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, Rinvoq was approved by the European Commission for the treatment of adult patients 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. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of Rinvoq in psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing. Use of Rinvoq in ankylosing spondylitis is not approved and its safety and efficacy have not been established by regulatory authorities.