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Positive CHMP opinion for UCB’s bimekizumab

Therapy concerns the treatment of adults with axial spondyloarthritis and psoriatic arthritis.

UCB has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted marketing authorisation for bimekizumab in the EU.

It concerns the treatment of adults with active axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). AxSpA is an indication that covers both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) – also known as radiographic axSpA (r-axSpA).

In active PsA, the CHMP recommended approval of bimekizumab alone or in addition to methotrexate, for the treatment of adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs.

Furthermore, in active axSpA, the CHMP recommended approval of bimekizumab for treating adults with active nr-axSpA with objective signs of inflammation.

Throughout all four relevant studies – BE OPTIMAL, BE COMPLETE, BE MOBILE 1 and BE MOBILE 2 – safety data was consistent with previous studies, including no new observed safety signals.

Meanwhile, the CHMP’s positive opinions on bimekizumab in active PsA and active axSpA will now be referred to the European Commission (EC), which will deliver a final decision over the coming months. Marketing authorisation will be valid across all EU member states in addition to Norway, Iceland, Northern Ireland and Liechtenstein.

If approved by the EC, these would become the second and third indications for bimekizumab in the EU, following its initial approval in 2021 for the treatment of moderate to severe plaque psoriasis among adult patient groups.

Emmanuel Caeymaex, executive vice president of immunology solutions at UCB, reflected: “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.”

He concluded: “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.”