Alfasigma Wins EU Approval for Filgotinib in Axial Spondyloarthritis

Alfasigma has received European Commission approval to expand the use of filgotinib for adults with active axial spondyloarthritis (axSpA), a chronic inflammatory disease that mainly affects the spine and joints.

Announced on November 5, 2026, the approval covers both radiographic and non-radiographic forms of the disease in adults who have not responded adequately to conventional treatment. The decision provides a new treatment option for patients in Europe who continue to experience symptoms despite existing therapies.

Filgotinib is an oral, once-daily medicine that works by selectively targeting the Janus kinase 1 (JAK1) pathway, which plays an important role in the body’s inflammatory response. The medicine is available in 100 mg and 200 mg tablets.

The expanded approval is based on results from the Phase 3 OLINGUITO clinical trial, which evaluated the safety and effectiveness of filgotinib in patients with active axial spondyloarthritis.

The trial included two separate studies involving patients with radiographic axial spondyloarthritis (r-axSpA) and non-radiographic axial spondyloarthritis (nr-axSpA). A total of 495 patients participated, with 258 in the radiographic study and 237 in the non-radiographic study.

Participants received either filgotinib 200 mg once daily or a placebo for 16 weeks. Researchers then evaluated improvements in disease symptoms, including spinal pain, inflammation and physical function.

Both studies met their primary endpoint at week 16. In the radiographic study, 39.5% of patients receiving filgotinib achieved an ASAS40 response, compared with 20.9% in the placebo group. In the non-radiographic study, the response rate was 34.5% with filgotinib compared with 17.8% with placebo.

Improvements were observed as early as the first week of treatment and continued through week 52. The study also showed reductions in total and night-time spinal pain, with improvements maintained or further increased during the treatment period.

Axial spondyloarthritis is a long-term inflammatory condition that mainly affects the spine and joints connecting the pelvis to the lower back. Common symptoms include persistent back pain, stiffness and reduced mobility. Some patients may also experience inflammation in other parts of the body, including the eyes, skin and digestive system.

Although several treatment options are available, many patients do not achieve adequate control of their symptoms. According to Alfasigma, around 40% to 50% of patients achieve a meaningful response to current treatments, while only a smaller proportion reach inactive disease.

Richard Azencoth, Global Chief Portfolio and Medical Strategy Officer at Alfasigma, said the European Commission’s decision represents an important step towards providing another treatment option for people living with axial spondyloarthritis.

The company also highlighted the importance of oral treatment options that can help doctors manage the disease according to individual patient needs.

The new approval adds to filgotinib’s existing uses in Europe and the United Kingdom, where it is approved for treating moderate to severe rheumatoid arthritis and ulcerative colitis.

Meanwhile, Alfasigma has submitted an application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the new axial spondyloarthritis indication. The application is currently under review.

The European approval strengthens Alfasigma’s presence in the inflammatory disease treatment market and expands the potential use of filgotinib across multiple immune-related conditions.