UCB, a global biopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions recommending granting marketing authorization for bimekizumab in the European Union (EU) for the treatment of adults with active axial spondyloarthritis (axSpA) and for adults with active psoriatic arthritis (PsA). AxSpA is an indication that spans both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA). If approved by the European Commission (EC), these would represent the second and third indications for bimekizumab in the EU, following its initial approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in August 2021.
“The positive CHMP opinion for two new indications for bimekizumab in Europe is a significant step towards our goal of delivering differentiated treatment options to patients. If approved, bimekizumab would be the first treatment for psoriatic arthritis and axial spondyloarthritis that inhibits IL-17F in addition to IL-17A. Positive results from the four Phase 3 clinical studies in PsA and axSpA showed that treatment with bimekizumab consistently resulted in deep levels of response that were rapid and sustained,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
In active PsA, the CHMP recommended approval of bimekizumab 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. The CHMP opinion is based on data from the Phase 3 BE COMPLETE and BE OPTIMAL studies recently published in The Lancet.2,3 The two studies met their primary and all ranked secondary endpoints with statistical significance at week 16.2,3 Long-term data from BE OPTIMAL showed that bimekizumab demonstrated sustained responses to week 52.4
In active axSpA, the CHMP recommended approval of bimekizumab 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 (r-axSpA) who have responded inadequately or are intolerant to conventional therapy. The positive CHMP opinion is based on data from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies, recently published in Annals of the Rheumatic Diseases.5 The two studies met their primary and all ranked secondary endpoints with statistical significance at week 16.5 Long-term data from both studies showed that bimekizumab demonstrated sustained responses to week 52.6
In all four studies (BE OPTIMAL, BE COMPLETE, BE MOBILE 1 and BE MOBILE 2) the safety data were consistent with previous studies with no new observed safety signals.2,3,5
The CHMP positive opinions on bimekizumab in active PsA and active axSpA will be referred to the EC, which will deliver a final decision within approximately two months. The marketing authorization will be valid in all member states of the European Union as well as Iceland, Norway, Northern Ireland and Liechtenstein.