Jyseleca - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
filgotinib
Post-authorisationHuman
On 17 September 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Jyseleca. The marketing authorisation holder for this medicinal product is Alfasigma S.p.A.
The CHMP adopted a new indication as follows:
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.
For information, the full indications for Jyseleca will be as follows:
Rheumatoid arthritis
Jyseleca 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 colitis
Jyseleca 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.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
CHMP post-authorisation summary of positive opinion for Jyseleca (VR0000325892)
Adopted
Reference Number: DOCID
English (EN) (141.46 KB - PDF)
First published: