Jyseleca gets EU axSpA approval, Alfasigma says

Alfasigma said the European Commission has approved Jyseleca, also known as filgotinib, for adults with active axial spondyloarthritis who have responded inadequately to conventional therapy.

The company said the additional indication covers both non-radiographic and radiographic forms of axial spondyloarthritis, or axSpA. It said an application for UK approval has been submitted to the Medicines and Healthcare products Regulatory Agency and is under review.

Alfasigma said the EU decision followed a positive CHMP opinion in September 2026 and was supported by data from the OLINGUITO Phase 3 trial. The company said the study found improvements in signs and symptoms of axSpA, including spinal pain, beginning early in treatment and maintained over 52 weeks.

Jyseleca was already approved in Europe and the United Kingdom for moderate to severe rheumatoid arthritis and ulcerative colitis, according to Alfasigma.