EMA Accepts Marketing Authorization Applications for UCB's Bimekizumab in Psoriatic Arthritis and Axial Spondyloarthritis

This move marks the first regulatory submissions for bimekizumab in psoriatic arthritis and axial spondyloarthritis worldwide.

The European Medicines Agency (EMA) has accepted for regulatory review the two marketing authorization applications for UCB's bimekizumab for the treatment of adult patients with active psoriatic arthritis (PsA), and adult patients with active axial spondyloarthritis (axSpA).

“These two regulatory applications in psoriatic arthritis and axial spondyloarthritis represent a significant milestone for bimekizumab as well as an important step towards expanding treatment options in the EU for these debilitating conditions. If approved for these two new indications, bimekizumab would be the first new treatment option in psoriatic arthritis and axial spondyloarthritis to selectively target IL-17F, in addition to IL-17A,” says Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB, in a news release.

The application in PsA is supported by data from the Phase 3 BE OPTIMAL and BE COMPLETE studies. In both studies, bimekizumab met the primary and all ranked secondary endpoints, achieving clinically relevant improvements over placebo in both joint and skin symptoms, with efficacy outcomes consistent across the biologic-naïve and TNF-inhibitor inadequate responder (TNFi-IR) populations. The application in active axSpA is based on data from the Phase 3 BE MOBILE 1 study in non-radiographic axSpA and the Phase 3 BE MOBILE 2 study in ankylosing spondylitis. Bimekizumab met the primary and all ranked secondary endpoints in both studies showing consistent improvements versus placebo in signs and symptoms across the full spectrum of axSpA, including non-radiographic axSpA and ankylosing spondylitis. Across all four Phase 3 studies the safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals.

In August 2021, bimekizumab received marketing authorization in countries of the European Union (EU)/European Economic Area (EEA) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The safety and efficacy of bimekizumab in PsA and axSpA have not been established, and it is not approved for use in PsA or axSpA by any regulatory authority worldwide.