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Taltz (ixekizumab)

Region

🇪🇺 EU

Active substance

ixekizumab

Company

Eli Lilly and Company (Ireland) Limited

Status

Authorised

Therapeutic area

Psoriasis; Arthritis, Psoriatic; Axial Spondyloarthritis; Arthritis, Juvenile

CHMP opinion

Thu 25 Feb 2016

EU approval

Mon 25 Apr 2016

Application

EMEA/H/C/003943

ATC

L04AC13

Official record

www.ema.europa.eu

Indication

Plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Paediatric plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy.Psoriatic arthritisTaltz, alone or in combination with methotrexate, 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 disease-modifying anti-rheumatic drug (DMARD) therapies. Axial spondyloarthritis Ankylosing spondylitis (radiographic axial spondyloarthritis)Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis 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).Juvenile idiopathic arthritis (JIA)Juvenile psoriatic arthritis (JPsA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.Enthesitis-related arthritis (ERA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, 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.