CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca ® (filgotinib), Treatment of Adults With Axial Spondyloarthritis

Alfasigma S.p.A, a global pharmaceutical company with a focus on innovation in rare disease and specialty care in areas where there is significant unmet patient need, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca^® (filgotinib), an oral, once-daily JAK1 preferential inhibitor, for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy. Following this positive opinion, the application is now referred to the European Commission (EC) for final action. The EC’s decision is expected in the next 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 impactful symptoms,” said Daniele D'Ambrosio, Chief Development Officer, Alfasigma. “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.”

“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.”

The positive opinion is based on data from the OLINGUITO Phase 3 trial, recently published in the Annals of the Rheumatic Diseases.ⁱ The OLINGUITO trial consists of two international, randomised, double-blind, placebo-controlled studies (Study A and Study B), evaluating the efficacy and safety of filgotinib 200 mg once daily vs. placebo in patients with an established diagnosis of axSpA.ⁱ Eligible patients met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for radiographic (r) (Study A) or non-radiographic (nr) axSpA (Study B) and had an inadequate response or intolerance to conventional treatments.ⁱ The primary endpoint was the proportion of patients who achieved an ASAS40* response at week 16. In both studies, filgotinib met the primary endpoint, with a significantly greater proportion of patients achieving ASAS40 response at week 16 vs. placebo in the r-axSpA study (39.5% vs. 20.9%; treatment difference 18.6% [95% CI 7.6, 29.6]; p=0.001) and nr-axSpA study (34.5% vs. 17.8% treatment difference 16.7% [95% CI 5.7, 27.6]; p=0.003).ⁱ ASAS40 responses occurred early (from week 1) with filgotinib and continued to increase up to week 52.ⁱ

Data from the OLINGUITO trial also demonstrated approximately 40-44% of patients receiving filgotinib achieved ASDAS inactive disease (ID) or low disease activity (LDA) at week 16, with the proportion of patients increasing to 58-61% at week 52; these trends were consistent irrespective of prior biologic disease-modifying antirheumatic drugs (DMARD) treatment.ⁱ Safety was consistent with the known safety profile of filgotinib, indicating a favourable benefit-risk profile for patients with active axSpA.ⁱ

Chronic back pain is the most common manifestation of axSpA.ⁱⁱ 70% of people living with axSpA report high pain intensity that impacts their quality of life and persists despite treatment,ⁱⁱⁱ making effective pain control a priority in disease management. Data showed that filgotinib delivered reductions in patient-assessed total and nocturnal spinal pain as early as week 4, which were maintained or further improved up to week 52.ⁱ

About OLINGUITO

OLINGUITO (NCT05785611) is a Phase 3 randomised, placebo-controlled, double-blind, parallel-group trial to evaluate the efficacy and safety of filgotinib in adult patients with active axSpA. The trial consists of two studies of patients with active axSpA who had an inadequate response or intolerance to conventional treatments. Study A included 258 patients with r-axSpA, while study B included 237 patients with nr-axSpA. Patients in both studies were randomised (1:1) to receive treatment with oral filgotinib 200mg, or matching placebo, once daily for 16 weeks.

The primary endpoint for both studies was the proportion of patients who achieved an Assessment of SpondyloArthritis international Society 40% improvement (ASAS40) at week 16. Patients aged <65 years and/or without pre-specified risk factors then entered an open-label treatment period in which they received filgotinib 200 mg once daily up to week 52. Those patients achieving sustained low disease activity or inactive disease at week 52 were re-randomised (1:1) to receive double-blind filgotinib 100 mg or 200 mg up to week 104 (dose de-escalation period).

At week 16, patients above 65 years of age and/or those with pre-specified risk factors received the lowest-effective dose (filgotinib 200mg or 100 mg once daily), based on their ASAS40 response, for the remainder of the study up to week 104.

About axial spondyloarthritis

Axial spondyloarthritis (axSpA) is a chronic inflammatory condition that primarily affects the axial skeleton (spine and sacroiliac joints). While persistent back pain and spinal stiffness are common initial symptoms, the disease often also presents with peripheral manifestations such as enthesitis, arthritis, and dactylitis, as well as extra-musculoskeletal features including uveitis, inflammatory bowel disease and psoriasis.^iv

AxSpA usually starts during the third decade of life and comprises the whole spectrum of patients with and without radiographic sacroiliitis, that is, radiographic axSpA (r-axSpA; also known as ankylosing spondylitis, i.e., the damage caused by the disease can be seen on X-rays) and non-radiographic axSpA (nr-axSpA), respectively.^iv

About filgotinib

Jyseleca^® (filgotinib) is currently approved by the relevant regulatory authorities in the European Union, United Kingdom, Japan, Taiwan, South Korea and Singapore. In Europe, United Kingdom, Japan, Taiwan, South Korea and Singapore, for the treatment of moderate to severe active rheumatoid arthritis in adults who have not responded adequately or cannot tolerate other DMARDs. Filgotinib is also approved in Europe, United Kingdom, Japan, Taiwan, South Korea and Singapore for the treatment of adult patients with moderate to severe active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Filgotinib 100 mg and 200 mg are registered in the above-mentioned territories.

The European Summary of Product Characteristics for filgotinib is available at www.ema.europa.eu. The United Kingdom Summary of Product Characteristics for filgotinib can be found at www.medicines.org.uk/emc. The interview from the Japanese Ministry of Health, Labor and Welfare is available at www.info.pmda.go.jp. The Taiwan Food and Drug Administration Assessment Report for filgotinib can be found at www.fda.gov.tw. The Korean Ministry of Food and Drug Safety report on filgotinib can be found here www.mfds.go.kr/eng/brd. The Singapore Summary of Product Characteristics for filgotinib can be found at www.hsa.gov.sg.

About Alfasigma

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group has products in over 100 markets spanning Europe, North and South America, Asia, and Africa. Alfasigma employs approximately 4,000 people. For more information, please visit www.alfasigma.com.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Alfasigma. Various known and unknown risks, uncertainties, and other factors could lead to material differences between the actual future results, financial situation, development, or performance of the company and the estimates given here. Alfasigma assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

_____________

* ASAS40: ≥40% improvement and an absolute improvement from baseline of ≥20 U (range 0–100) in ≥ three of the following four domains: back pain [10 cm visual analogue scale (VAS)], patient global assessment of disease activity (10 cm VAS), physical function (BASFI; range 0–100) and inflammation (mean score of items 5 and 6 of the BASDAI; both 10 cm VAS) without any worsening in the remaining domain. (Sieper J, et al. Ann Rheum Dis. 2009)

i Baraliakos X, et al. Efficacy and safety of filgotinib in patients with active radiographic and nonradiographic axial spondyloarthritis: results from OLINGUITO, a phase 3 trial consisting of 2 randomised, placebo-controlled, double-blind, parallel-group studies. Annals of the Rheumatic Diseases. 2026 Aug 12.

ii Barnett R, et al. Axial spondyloarthritis 10 years on: still looking for the lost tribe. Rheumatology. 2020;59(Suppl4):iv25-iv37.

iii Garrido-Cumbrera M, et al. POS0508 what factors are associated with pain intensity in axial spondyloarthritis? Results from the International Map of Axial Spondyloarthritis (IMAS). Annals of the Rheumatic Diseases. 2024 Jun 1;83:917-8.

iv Navarro-Compán V, et al. Axial spondyloarthritis. Lancet. 2025;405:159-72.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260915829420/en/