AbbVie Submits New Indication Applications in the US and EU for Oral JAK Inhibitor Rinvoq to Treat Active Ankylosing Spondylitis
Aug 26, 2020 15:47
CST Updated
15:47
AbbVie
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FDA
U.S. Food and Drug Administration
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
August 26, 2020 /BioValleyBIOON/ -- AbbVie recently announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) submitted a new indication application for Rinvoq (upadacitinib), which is aSelective, Reversible JAK Inhibitors, for the treatment of adult patients with active ankylosing spondylitis (AS). Earlier this year, the company also submitted an application to the European Medicines Agency (EMA) for Rinvoq for the treatment of adult patients with active AS who have had an inadequate response to conventional therapy.
Ankylosing Spondylitis (AS) is a chronic, progressive, inflammatory musculoskeletal disease affecting more than 5 million people worldwide. The various symptoms of this condition impose significant physical, psychological, and economic burdens on patients.
The new indication application for Rinvoq in the treatment of adult patients with active AS is supported by data from the Phase 2/3 SELECT-AXIS 1 study (NCT03178487). The results showed that,Rinvoq Significantly Improved Symptoms and Signs in Adult Patients with Active Ankylosing Spondylitis Compared with Placebo, proportion of patients achieving ASAS40 (Assessment of SpondyloArthritis international Society 40% improvement) at Week 14 of treatmentDoubled (52% vs. 26%, p < 0.001).
Dr. Michael Severino, Vice Chairman and President of AbbVie, stated, “Ankylosing spondylitis (AS) is a debilitating disease that causes severe pain, limited mobility, and lasting structural damage. With limited treatment options available, innovation is critical to helping more patients with active AS achieve their treatment goals. Rinvoq has the potential to improve care by helping to provide disease control, relieve pain, and improve function. We look forward to working with regulatory authorities and hope to bring this important treatment option to patients.”
Ankylosing Spondylitis (Image source: rehabmypatient.com)
SELECT-AXIS 1 is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, Phase II/III study conducted in adult patients with active ankylosing spondylitis (AS) who are biologic disease-modifying antirheumatic drug-naive (bDMARD-naive) and have had an inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs), or are intolerant to or have contraindications for NSAIDs, aiming to evaluate the safety and efficacy of Rinvoq compared with placebo.
This study comprises two phases. Phase 1 lasts 14 weeks, with the primary endpoint being the proportion of patients achieving ASAS40 response (Assessment of SpondyloArthritis international Society 40% improvement) after 14 weeks of treatment. Secondary endpoints include: the proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 and ASAS Partial Response (PR) at Week 14; changes from baseline in the Ankylosing Spondylitis Disease Activity Score (ASDAS), MRI Spondyloarthritis Research Consortium of Canada (SPARCC) score (spine), and Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14. Phase 2 is an open-label extension period to evaluate the long-term safety, tolerability, and efficacy of Rinvoq in patients who have completed Phase 1.
Results from the first stage of the study demonstrated that the primary endpoint was met: at Week 14, the proportion of patients achieving ASAS40 (Assessment in SpondyloArthritis international Society 40% improvement) in the Rinvoq (15 mg, once daily) treatment group was double that of the placebo group (52% vs. 26%, p<0.001). After multiplicity adjustment, Rinvoq treatment showed statistically significant differences compared with placebo at Week 14 for the following endpoints: ASDAS, SPARCC MRI spine, BASDAI50, ASAS PR, and BASFI. Based on nominal p-values, all other endpoints were significant except for WPAI. The safety profile of Rinvoq in the treatment of ankylosing spondylitis (AS) in this study was consistent with previously reported findings from other clinical trials, including classRheumatoid Arthritis, atopic dermatitis, psoriatic arthritis, no new significant safety risks were identified.
Ankylosing spondylitis (AS) is a chronic, progressive, inflammatory disease that begins in early adulthood and primarily causes pain and stiffness in the spine. Apart from biologics, treatment options are limited for patients who have an inadequate response to or contraindications for nonsteroidal anti-inflammatory drugs (NSAIDs). The results of the SELECT-AXIS 1 study highlight the potential of Rinvoq as an additional treatment option for patients with AS.
The active pharmaceutical ingredient of Rinvoq is upadacitinib, an oral, selective, and reversible JAK1 inhibitor discovered and developed by AbbVie, which is being developed for the treatment of several immune-mediated inflammatory diseases. JAK1 is a kinase that plays a key role in the pathophysiology of various inflammatory diseases.
In August 2019, Rinvoq received its first global approval in the United States for the treatment of moderate to severe active rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate (MTX).Rheumatoid Arthritis(RA) adult patients. In December 2019, Rinvoq received European Union approval for the treatment of adult patients with moderate to severe RA who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). The approved dose of Rinvoq for RA is 15 mg.
Currently, Phase III clinical studies of Rinvoq for the treatment of psoriatic arthritis (PsA), rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), Crohn’s disease (CD), atopic dermatitis (AD), ulcerative colitis (UC), and giant cell arteritis (GCA) are ongoing.
In June this year, AbbVie announced the submission of a new indication application for Rinvoq (upadacitinib, 15 mg, once daily) in the United States and the European Union for the treatment of adult patients with active psoriatic arthritis (PsA).
The industry is highly optimistic about the commercial prospects of Rinvoq. The pharmaceutical market research firm EvaluatePharma previously released a report predicting that Rinvoq’s global sales would reach $2.57 billion in 2024, making it the fifth best-selling antirheumatic drug worldwide. (Bioon.com)