Alfasigma has received expanded approval from the European Commission (EC) for Jyseleca (filgotinib) to treat adult patients living with active axial spondyloarthritis (axSpA).
The additional indication approval covers radiographic and non-radiographic forms of the chronic inflammatory disease in individuals who show an inadequate response to conventional therapy.
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Alfasigma has also submitted a marketing authorisation application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which is currently reviewing the filing.
The EC approval is supported by findings from the Phase III OLINGUITO programme published in the Annals of the Rheumatic Diseases.
The clinical programme evaluated the efficacy and safety of oral once-daily filgotinib 200mg compared with placebo across two randomised, double-blind trials: Study A, which recruited 258 patients with radiographic axSpA (r-axSpA); and Study B, which involved 237 participants with non-radiographic axSpA (nr-axSpA).
All enrolled patients met Assessment of SpondyloArthritis international Society criteria and had experienced intolerance or an insufficient response to standard care.
Both trials met their primary endpoint at week 16, demonstrating statistically significant ASAS40 response rates over placebo.
In Study A, 39.5% of filgotinib recipients achieved an ASAS40 response versus 20.9% on placebo, representing an 18.6% treatment difference.
In Study B, 34.5% reached the endpoint compared with 17.8% in the control arm, yielding a 16.7% difference.
Alfasigma global chief portfolio and medical strategy officer Richard Azencoth said: “We welcome the EC’s decision to expand filgotinib’s licence and provide a new treatment option for people living with axSpA in Europe.
“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.”
axSpA typically emerges in patients in their 30s, affecting the axial skeleton and causing persistent back pain and spinal stiffness.
An oral JAK1 preferential inhibitor available in 100mg and 200mg tablets, Jyseleca is already authorised for moderate to severe active rheumatoid arthritis and moderately to severely active ulcerative colitis across the EU, Japan, Singapore, South Korea, Taiwan, and the UK.
In August 2026, Alfasigma agreed to purchase Nordic Group, a move aimed at strengthening its speciality care business and expanding its reach in Europe, Canada, and Japan.
