EC approves Bimzelx for new indications

The European Commission (EC) has granted marketing authorization 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.

According to Belgium pharma UCB (Euronext: UCB), the developer of this interleukin (IL)-17F and IL-17A blocking antibody, 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.

“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 US UCB, adding: “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.”