← Drug database

Jyseleca (filgotinib)

Region

🇪🇺 EU

Active substance

filgotinib

Company

Alfasigma S.p.A.

Status

Authorised

Therapeutic area

Arthritis, Rheumatoid

CHMP opinion

Thu 23 Jul 2020

EU approval

Thu 24 Sep 2020

Application

EMEA/H/C/005113

ATC

L04AF04

Official record

www.ema.europa.eu

Indication

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.

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.