Bimzelx gets recommendation for psoriatic arthritis in the EU

[Forest Walker]

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UCB today 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.

“The European Commission’s parallel approval of bimekizumab in PsA and axSpA builds on the momentum created since its first approval in moderate to severe plaque psoriasis and marks an exciting milestone offering healthcare professionals and patients the first IL-17A and IL-17F inhibitor for treatment of these diseases,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “The extended approval for bimekizumab in the European Union reflects our commitment to address unmet patient needs, improve patient outcomes and raise standards of care.” 

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.

Source: ucb.com

This is good news!