European Commission approvals for Bimzelx for the treatment of psoriatic arthritis and axial spondyloarthritis including non-radiographic axSpA and ankylosing spondylitis
UCB, a global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorisation for Bimzelx(bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA
These approvals in the European Union (EU) represent the first marketing authorizations for bimekizumab in PsA and axSpA worldwide, and the second and third indications for bimekizumab in the EU, following its approval for the treatment of moderate to severe plaque psoriasis in August 2021.
In PsA, bimekizumab is approved alone or in combination with methotrexate for the treatment of adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). In axSpA, bimekizumab is approved for the treatment of adults with active nr-axSpA with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs, and for the treatment of adults with active AS who have responded inadequately or are intolerant to conventional therapy.
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