UCB files for EU regulatory approval of bimekizumab in HS

The European Medicines Agency (EMA) has accepted for review the marketing authorization application for bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), submitted by Belgium’s largest pharma company UCB (Euronext: UCB).

“This EU regulatory submission for bimekizumab reflects our pursuit to address unmet patient needs and to advance standards of care in hidradenitis suppurativa, especially given that few treatment options are available today. If approved, this would represent the fourth indication for bimekizumab in the European Union across a range of IL-17 mediated diseases,” said Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB.

In August 2021, under the trade name Bimzelx, bimekizumab was first approved in the European Union (EU)/European Economic Area (EEA) and in Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Last month, Bimzelx was approved for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA).