CHMP Recommends EU Approval of New Indication for Alfasigma's Jyseleca (filgotinib)
核心洞察
The EMA's CHMP has issued a positive opinion for Alfasigma (搜索)'s Jyseleca (filgotinib) in active axial spondyloarthritis (搜索), covering both non-radiographic and radiographic forms.
The opinion rests on the Phase 3 OLINGUITO programme, where filgotinib 200 mg met the ASAS40 primary endpoint at week 16 in both Study A and Study B.
The application now goes to the European Commission for final action, with a decision expected in the coming weeks.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca (filgotinib), an oral, once-daily JAK1 (搜索) preferential inhibitor, for the treatment of adults with active axial spondyloarthritis (搜索) (axSpA), both non-radiographic and radiographic forms, who have responded inadequately to conventional therapy. Alfasigma (搜索) said the application is now referred to the European Commission for final action, with a decision expected in the next weeks.
The opinion is based on data from the OLINGUITO Phase 3 trial, published in the Annals of the Rheumatic Diseases. OLINGUITO comprises two international, randomised, double-blind, placebo-controlled studies: Study A enrolled 258 patients with radiographic axSpA and Study B enrolled 237 patients with non-radiographic axSpA, all with an inadequate response or intolerance to conventional treatment. Patients were randomised 1:1 to oral filgotinib 200 mg or placebo once daily for 16 weeks. Filgotinib met the primary endpoint of ASAS40 response at week 16 in both studies, at 39.5% versus 20.9% in the radiographic study (treatment difference 18.6%, 95% CI 7.6 to 29.6; p=0.001) and 34.5% versus 17.8% in the non-radiographic study (treatment difference 16.7%, 95% CI 5.7 to 27.6; p=0.003). Responses occurred from week 1 and continued to increase to week 52.
Approximately 40% to 44% of filgotinib-treated patients achieved ASDAS inactive disease or low disease activity at week 16, rising to 58% to 61% at week 52, with consistent trends regardless of prior biologic DMARD treatment. Reductions in patient-assessed total and nocturnal spinal pain were reported from week 4 and were maintained or further improved through week 52. Safety was consistent with the known profile of filgotinib. Jyseleca is currently approved in the European Union, United Kingdom, Japan, Taiwan, South Korea and Singapore for moderate to severe active rheumatoid arthritis (搜索) and for moderate to severe active ulcerative colitis (搜索).
Source: AFP