European Commission expands license for Alfasigma’s Jyseleca ® (filgotinib) with approval of new indication, treatment of adults with axial spondylarthritis

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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 Commission (EC) has approved an additional indication to Jyseleca^® (filgotinib) 200 mg and 100 mg film-coated tablets, 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. A submission for UK approval has been made to the Medicines and Healthcare products Regulatory Agency (MHRA) and is under review.

The European Commission’s approval is based on data that support a favourable benefit-risk profile for filgotinib, including efficacy and safety findings from the OLINGUITO Phase 3 clinical trial published this year in the Annals of the Rheumatic Diseases.ⁱ Results from the study showed improvements in signs and symptoms of axSpA with filgotinib observed as early as week 1 and maintained over 52 weeks of treatment.ⁱ

“We welcome the European Commission’s decision to expand filgotinib’s license and provide a new treatment option for people living with axSpA in Europe,” said Richard Azencoth, Global Chief Portfolio and Medical Strategy Officer, Alfasigma. “AxSpA is a lifelong condition that presents long-term management challenges, and despite the availability of several advanced therapies, currently half of the patients fail to adequately respond to treatment. Approval of a new disease-modifying anti-rheumatic drug is an important step for those living with axSpA, and we are working with authorities within Europe to translate approval into appropriate access.”

Despite several efficacious anti-inflammatory treatment options, only about 40% to 50% of patients with axSpA achieve a relevant treatment response, and an even smaller proportion (approx. 10-20%) reach remission or an inactive disease activity state within 16 to 24 weeks of treatment initiation.ⁱⁱ Chronic back pain is the most common manifestation of axSpA.ⁱⁱⁱ 70% of people living with axSpA report high pain intensity that impacts their quality of life and persists despite treatment,^iv making effective pain control a priority in disease management. In the OLINGUITO Phase 3 clinical trial, approximately 40-44% of patients receiving filgotinib achieved ASDAS inactive disease (ID) or low disease activity (LDA) at week 16, a proportion that increased to 58-61% at week 52; these trends were consistent irrespective of prior biologic disease-modifying antirheumatic drugs (bDMARD) treatment.ⁱ

Data from the study also 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

“Despite advances in the management of axial spondyloarthritis, many patients continue to experience persistent symptoms that affect their daily lives, work, and overall well-being,” 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. “European Commission approval of filgotinib provides physicians and patients with an additional treatment option that has demonstrated improvements across key manifestations of axial spondyloarthritis. Expanding the therapeutic landscape to include additional treatment options, including oral therapies, could help physicians support patients with a more individualised approach to patient care.”

The OLINGUITO Phase 3 clinical 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. 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.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). ASAS40 responses occurred early (from week 1) with filgotinib and continued to increase up to week 52. Safety was consistent with the known safety profile of filgotinib, indicating a favourable benefit-risk profile for patients with active axSpA.ⁱ

About OLINGUITO study design (NCT05785611)

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.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.

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*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)

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.^v

AxSpA usually affects people in their thirties 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.^v

About filgotinib

Jyseleca^® (filgotinib) is currently approved by the relevant regulatory authorities in the European Union, United Kingdom, Japan, Taiwan, South Korea and Singapore for the following indications:

In Europe, for the treatment of patients with:

• Non-radiographic axial spondyloarthritis (nr-axSpA), Jyseleca is indicated for the treatment of active non-radiographic axial spondyloarthritis 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).
• Ankylosing spondylitis (AS, radiographic axial spondyloarthritis [r-axSpA]), Jyseleca is indicated for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis) in adult patients who have responded inadequately to conventional therapy.

A marketing authorisation application has been submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) and is currently under review.

In Europe, United Kingdom, Japan, Taiwan, South Korea and Singapore, Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).

In Europe, United Kingdom, Japan, Taiwan, South Korea and Singapore, Jyseleca is indicated for the treatment of adult patients with moderately to severely 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 film-coated tablets 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

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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 Poddubnyy D, et al. The Assessment of SpondyloArthritis International Society (ASAS) consensus-based expert definition of difficult-to-manage, including treatment-refractory, axial spondyloarthritis. Annals of the Rheumatic Diseases. 2025;84(4):538-46.

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

^iv 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;83:917-8.

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

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