Jyseleca

filgotinib · Alfasigma S.p.A.
AUTHORISED IN THE EU

What Jyseleca is used for

Rheumatoid arthritisJyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Ulcerative colitisJyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Jyseleca is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis [r-axSpA]) Jyseleca is indicated for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis) in adult patients who have responded inadequately to conventional therapy.

Approved use, as published by the European Medicines Agency.

Key facts

Brand
Jyseleca
Active substance
filgotinib
Disease area
Arthritis, Rheumatoid
Medicine group
Immunosuppressants
ATC code
L04AF04
Marketing authorisation holder
Alfasigma S.p.A.
Authorised in the EU since
2020

Official information

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Jyseleca used for?

Rheumatoid arthritisJyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Ulcerative colitisJyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Axial spon…

What is the active substance in Jyseleca?

Jyseleca contains filgotinib.

Who makes Jyseleca?

The EU marketing authorisation holder is Alfasigma S.p.A..

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

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