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BIMZELX (UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia)

Product name
BIMZELX
Sponsor
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
Date registered
Evaluation commenced
Decision date
Approval time
220 (255 working days)
Active ingredients
bimekizumab
Registration type
EOI
Indication

Psoriatic arthritis

Bimzelx is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response to or who have been intolerant to previous disease modifying antirheumatic drug (DMARD) therapy.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

Bimzelx 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 had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

Bimzelx is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

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