MILAN, Italy — September 18, 2026
Alfasigma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a new indication for filgotinib in adults with active axial spondyloarthritis (axSpA), including both radiographic and non-radiographic forms, who have responded inadequately to conventional therapy. The recommendation is now subject to review by the European Commission, with a final decision expected in the coming weeks. Filgotinib is an oral, once-daily JAK1 preferential inhibitor already approved in Europe and other markets for rheumatoid arthritis and ulcerative colitis.
OLINGUITO Phase 3 Trial Demonstrates Clinical Benefit
The CHMP opinion is supported by results from the Phase 3 OLINGUITO program, which included two randomized, double-blind, placebo-controlled studies evaluating filgotinib 200 mg once daily in patients with radiographic or non-radiographic axSpA. At week 16, filgotinib significantly increased the proportion of patients achieving an ASAS40 response compared with placebo in both study populations. In radiographic axSpA, ASAS40 response was achieved by 39.5% of patients receiving filgotinib versus 20.9% with placebo, while the corresponding rates in non-radiographic axSpA were 34.5% and 17.8%. Responses emerged as early as week 1 and continued to increase through week 52.
Filgotinib Provides Sustained Disease Activity and Pain Improvements
OLINGUITO data showed sustained improvements in disease activity, inflammation, pain and quality of life through 52 weeks. Approximately 40–44% of patients receiving filgotinib achieved ASDAS inactive disease or low disease activity at week 16, increasing to 58–61% at week 52. The trends were consistent regardless of prior biologic DMARD treatment. Patient-reported assessments also showed reductions in total and nocturnal spinal pain beginning at week 4, with improvements maintained or further increased through week 52. Alfasigma said the safety findings were consistent with the known safety profile of filgotinib.
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Alfasigma Advances Filgotinib Across Inflammatory Diseases
The positive CHMP opinion expands the potential European use of filgotinib into axSpA, a chronic inflammatory disease that primarily affects the spine and sacroiliac joints and can cause persistent back pain and stiffness. The OLINGUITO program enrolled 495 patients across radiographic and non-radiographic axSpA studies, with participants receiving once-daily filgotinib or placebo during the initial 16-week period. Patients meeting specified criteria could continue treatment through longer-term follow-up and dose de-escalation. Filgotinib is already approved in multiple markets for moderate-to-severe rheumatoid arthritis and ulcerative colitis, and the proposed axSpA indication would further expand Alfasigma’s specialty-care portfolio.
Source : Alfasigma, press release
