The information contained within this press release is for the purpose of scientific exchange. It is intended for scientific, financial and investor media only. If approved, Jyseleca will be indicated for adults with active axial spondyloarthritis. The indication covers both non-radiographic and radiographic forms. It targets patients who responded inadequately to conventional therapy.
Despite several available treatment options, many people with axial spondyloarthritis remain inadequately treated. Nearly half of patients do not respond adequately to current therapies. Only 10-20% reach inactive disease within 16-24 weeks after starting treatment. The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued the positive opinion. The recommendation supports Jyseleca® (filgotinib) for active axial spondyloarthritis. The medicine is an oral, once-daily JAK1 preferential inhibitor.
Following the CHMP opinion, the application moves to the European Commission. The European Commission will make the final decision. The decision is expected in the coming weeks.
“At present, half of people living with axSpA fail to adequately respond to treatment, leaving them with years of preventable struggle with persistent pain and other i said Daniele D’Ambrosio, Chief Development Officer, Alfasigma. mpactful symptoms,”“This positive opinion was based on data that showed early and sustained improvements in the signs and symptoms of axSpA with filgotinib, including disease activity, inflammation, pain, and quality of life, and marks meaningful progress towards meeting unmet needs in a painful, lifelong condition.”
OLINGUITO Phase 3 Data Support Jyseleca
The positive CHMP opinion relies on findings from the OLINGUITO Phase 3 trial. The study evaluated the efficacy and safety of filgotinib in patients with axial spondyloarthritis. The results were recently published in the Annals of the Rheumatic Diseases. The OLINGUITO program included two international studies. Both studies were randomised, double-blind, and placebo-controlled.
Study A evaluated patients with radiographic axial spondyloarthritis. Study B assessed patients with non-radiographic axial spondyloarthritis. Both studies compared filgotinib 200 mg once daily with placebo. Eligible patients met the Assessment of SpondyloArthritis international Society classification criteria. Participants also had inadequate responses or intolerance to conventional treatments. The primary endpoint measured ASAS40 response at week 16. Filgotinib achieved the primary endpoint in both studies.
In the radiographic study, 39.5% of patients receiving filgotinib achieved ASAS40. In comparison, 20.9% of placebo patients achieved the same response. The treatment difference was 18.6%. The 95% confidence interval ranged from 7.6 to 29.6. The study reported a p-value of 0.001. In the non-radiographic study, 34.5% of patients receiving filgotinib achieved ASAS40. Meanwhile, 17.8% of placebo patients achieved the response. The treatment difference was 16.7%.
The 95% confidence interval ranged from 5.7 to 27.6. The study reported a p-value of 0.003. Importantly, ASAS40 responses appeared as early as week one. The response also continued to increase through week 52. The OLINGUITO findings further showed improvements in disease activity. Approximately 40-44% of patients achieved ASDAS inactive disease or low disease activity at week 16. By week 52, that proportion increased to 58-61%. These trends remained consistent regardless of previous biologic disease-modifying antirheumatic drug treatment. Safety results remained consistent with the established safety profile of filgotinib. The findings therefore indicated a favourable benefit-risk profile for patients with active axial spondyloarthritis.
Axial Spondyloarthritis and Patient Quality of Life
Axial spondyloarthritis is a chronic inflammatory disease. It commonly affects people before they reach 40 years of age. Symptoms can also begin during a person’s 20s. The condition can restrict mobility and reduce quality of life. It can also affect people during important professional and social periods.
“AxSpA is a chronic inflammatory disease that usually strikes people under 40 years old – although onset can be as early as their 20s – limiting mobility and impairing quality of life, typically within a period characterised by considerable activity in occupational, social, and economic spheres,” said Prof. Xenofon Baraliakos, Head of Rheumatology at the Rheumazentrum Ruhrgebiet Herne, and Professor of Internal Medicine and Rheumatology at the Ruhr-University Bochum, Germany. “If approved, the efficacy and safety profile of filgotinib, coupled with the convenience of oral administration, position the drug as a valuable new treatment option for patients with active axSpA.”
Chronic back pain remains the most common manifestation of axial spondyloarthritis. Around 70% of people with the condition report high pain intensity. The pain can affect daily quality of life and may continue despite treatment. Therefore, effective pain management remains an important part of disease management. Data from the OLINGUITO trial showed reductions in spinal pain with filgotinib. Patients reported improvements in both total and nocturnal spinal pain.
These improvements appeared as early as week four. Furthermore, the reductions continued or improved through week 52. Jyseleca already holds approvals in Europe and the United Kingdom. Those approvals cover moderate to severe rheumatoid arthritis and ulcerative colitis. The latest CHMP opinion expands the potential treatment role of Jyseleca. It also highlights the ongoing development of filgotinib for patients with unmet needs in inflammatory diseases.
If the European Commission approves the application, Jyseleca could become an additional oral treatment option for eligible patients with active axial spondyloarthritis. This version keeps the original scientific data and statements intact while restructuring the surrounding content for clearer news flow and SEO. The unchanged quotes may contain sentences longer than 20 words because the source statements were required to remain verbatim.
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News Source: Businesswire.com
