UCB announces approval of Bimzelx

The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis

UCB has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Bimzelx, also known as bimekizumab.

The therapy is used for the treatment of adult patients with active psoriatic arthritis (PsA) and adult patients with active axial spondyloarthritis (axSpA).

Bimzelx is the first approved treatment for PsA and axSpA that has been developed to inhibit IL-17A and IL-17F – two key cytokines driving the inflammatory process.

The MHRA has approved bimekizumab alone or in combination with methotrexate for the treatment of adults with active PsA who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.

In active axSpA, the MHRA has approved 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.

Across the PsA studies, bimekizumab showed improvements compared to placebo in joint and skin symptoms across biologic-naïve and TNF inhibitor-inadequate responder populations. In the axSpA studies, the drug demonstrated improvements compared to placebo in signs, symptoms and disease activity across the spectrum of the condition.

Claire Brading, managing director UK and Ireland at UCB, reflected: “The approval of Bimzelx in psoriatic arthritis and axial spondyloarthritis is a significant milestone for the rheumatology community in the UK. At UCB we are committed to exploring innovative solutions that enable patients to maintain disease control and live their lives as free as possible from the burden of their condition.”

She concluded: “We are extremely proud to be able to bring a new dual action biological treatment option to a broad range of people living with psoriatic arthritis and axial spondyloarthritis in the UK.”