Alfasigma secures EU approval for Jyseleca to treat axial spondyloarthritis
The expanded indication covers both radiographic and non-radiographic forms of axSpA in adults who have not responded adequately to conventional treatment or cannot tolerate it.
UK—Alfasigma has secured European Commission (EC) approval to expand the use of Jyseleca (filgotinib) to treat adults with active axial spondyloarthritis (axSpA), a chronic inflammatory disease affecting the spine and joints.
The expanded indication covers both radiographic and non-radiographic forms of axSpA in adults who have not responded adequately to conventional treatment or cannot tolerate it.
Alongside the European approval, Alfasigma has submitted a marketing authorisation application to the UK Medicines and Healthcare products Regulatory Agency (MHRA), which is currently reviewing the submission.
Phase III trials demonstrate treatment efficacy
The EC decision follows positive findings from the Phase III OLINGUITO clinical programme, published in Annals of the Rheumatic Diseases.
The programme assessed the efficacy and safety of once-daily oral filgotinib 200mg against placebo in two randomised, double-blind clinical trials.
Study A enrolled 258 patients with radiographic axial spondyloarthritis (r-axSpA), while Study B involved 237 participants with non-radiographic axial spondyloarthritis (nr-axSpA).
All participants met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria and had either an inadequate response or intolerance to standard treatment.
Both studies achieved their primary endpoint at week 16, with filgotinib demonstrating statistically significant improvements in ASAS40 response rates compared with placebo.
In Study A, 39.5% of patients receiving filgotinib achieved an ASAS40 response, compared with 20.9% in the placebo group, representing an 18.6 percentage-point difference.
Similarly, Study B recorded an ASAS40 response in 34.5% of patients receiving filgotinib, compared with 17.8% of those receiving placebo, a difference of 16.7 percentage points.
Richard Azencoth, Alfasigma’s Global Chief Portfolio and Medical Strategy Officer, welcomed the EC decision, saying it would provide another treatment option for people living with axSpA across Europe.
He noted that axSpA presents lifelong management challenges and that, despite the availability of several advanced therapies, approximately half of patients do not respond adequately to treatment.
Azencoth added that the approval of another disease-modifying antirheumatic drug (DMARD) represents an important development for patients.
The company is working with European regulatory authorities to facilitate appropriate access to the treatment.
Jyseleca expands its treatment portfolio
Axial spondyloarthritis typically develops in people in their 30s and affects the axial skeleton, causing persistent back pain, inflammation and spinal stiffness.
Jyseleca is an oral, preferential Janus kinase 1 (JAK1) inhibitor available in 100mg and 200mg tablets.
The medicine is already authorised to treat adults with moderate to severe active rheumatoid arthritis and moderately to severely active ulcerative colitis in the European Union, Japan, Singapore, South Korea, Taiwan and the UK.
In August 2026, Alfasigma agreed to acquire Nordic Group as part of its strategy to strengthen its speciality care business and expand its presence across Europe, Canada and Japan.
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