New FDA approvals for UCB’s Bimzelx

The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS).

With three new indications, Bimzelx, from Belgium’s largest pharma company UCB (Euronext: UCB), is the first and only interleukin (IL)-17A and IL-17F inhibitor approved in the US for the treatment of four chronic immune-mediated inflammatory diseases. UCB’s shares were up 2.4% at 166.66 euros by midday trading.

Last month UCB received marketing authorization from the European Commission for two new 320 mg device presentations of Bimzelx (bimekizumab), a pre-filled syringe and pen.