EU Expands Jyseleca Approval for Axial Spondyloarthritis
The European Commission has approved filgotinib for adults with active axial spondyloarthritis who respond inadequately to conventional therapy.
Updated on Nov. 6, 2026 in Arthritis
The European Commission approved expanded use of Jyseleca (filgotinib) to treat adult patients with active axial spondyloarthritis, covering both radiographic and non-radiographic forms. Alfasigma has also submitted a marketing authorisation application to the UK MHRA, which is currently under review.
Why it matters
The approval extends a treatment option to patients who have not responded adequately to conventional therapy for a chronic inflammatory condition affecting the spine and joints. It also broadens Jyseleca's authorised indications beyond rheumatoid arthritis and ulcerative colitis.
In the Phase III OLINGUITO trials, 39.5% of patients with radiographic axSpA on 200mg filgotinib achieved an ASAS40 response versus 20.9% on placebo at week 16, and 34.5% of non-radiographic participants versus 17.8% on placebo. Longer-term outcomes and safety beyond the primary endpoint were not included in the extraction.
The players
European Commission
The executive body of the European Union responsible for proposing legislation and approving medicines authorisations across member states.
Alfasigma
An Italian pharmaceutical company that markets Jyseleca and has submitted a UK marketing application for the expanded indication.
The details
Both trials, published in the Annals of the Rheumatic Diseases, evaluated oral once-daily filgotinib 200mg against placebo in randomised, double-blind designs. All enrolled patients met ASAS criteria and had experienced intolerance or insufficient response to standard care.
Timeline
Week 16: both trials met their primary endpoint.
August 2026: Alfasigma agreed to purchase Nordic Group.
November 6, 2026: the European Commission's expanded approval was announced.
Health Landscape
The approval expands Jyseleca's use within the EU centralised authorisation framework, which already covers its rheumatoid arthritis and ulcerative colitis indications. It places filgotinib among oral JAK-inhibitor options for chronic inflammatory conditions, where patients often move between treatments after conventional therapy fails.
Adults with active axial spondyloarthritis who have not responded adequately to conventional treatment may now have an oral once-daily option available in the EU. Patients in the UK will need to wait for the MHRA review outcome before the same indication is available there.
The takeaway
Patients with axial spondyloarthritis who have not responded to standard care now have an additional oral treatment option in the EU. Discuss eligibility and the trial evidence with a rheumatologist to understand whether it fits an individual treatment plan.
What happens next
The UK MHRA is currently reviewing Alfasigma's marketing authorisation application for the expanded indication, with no decision date reported in the extraction.
Further reading
For more on the disease at the centre of this approval, see our Arthritis coverage.
Source note: This article includes information reported by Pharmaceutical Technology.
