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Rinvoq (upadacitinib)

Region

🇪🇺 EU

Active substance

upadacitinib

Company

AbbVie Deutschland GmbH & Co. KG

Status

Authorised

Therapeutic area

Arthritis, Rheumatoid; Arthritis, Psoriatic; Axial Spondyloarthritis; Spondylitis, Ankylosing; Giant Cell Arteritis; Dermatitis, Atopic; Colitis, Ulcerative; Crohn Disease; Alopecia Areata; Vitiligo

CHMP opinion

Thu 17 Oct 2019

EU approval

Mon 16 Dec 2019

Application

EMEA/H/C/004760

ATC

L04AA44

Official record

www.ema.europa.eu

Indication

Rheumatoid arthritis Rinvoq 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). Rinvoq may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. Polyarticular juvenile idiopathic arthritis   Rinvoq is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.  Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA)  Rinvoq 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)  Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Giant cell arteritis Rinvoq is indicated for the treatment of giant cell arteritis in adult patients. Atopic dermatitis Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Alopecia areata Rinvoq is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Vitiligo Rinvoq is indicated for the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.  Crohn’s disease Rinvoq is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

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.