The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending UCB’s Bimzelx (bimekizumab), with the inflammatory disease drug now authorised by the institute to treat adults with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).
Bimzelx, which is already authorised in the UK to treat certain patients with plaque psoriasis, is now the first treatment available for PsA and axSpA that is designed to inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory disease.
NICE’s guidance follows a recent approval from the Medicines and Healthcare products Regulatory Agency (MHRA) and was expedited through the institute’s proportionate approach to the technology appraisal pathway, which allows eligible patients to access Bimzelx earlier than under the routine approval processes.
PsA and axSpA are two forms of chronic inflammatory arthritis, affecting over 800,000 people in the UK combined.
In PsA, Bimzelx is now recommended alone or in combination with methotrexate to treat patients with active disease who have had an inadequate response or have been intolerant to disease-modifying antirheumatic drugs. The drug is recommended after patients have received one biological or targeted synthetic DMARD, or if TNF-alpha inhibitors are contraindicated but would otherwise be considered.
The approval was supported by results from two phase 3 trials in which Bimzelx showed improvements over placebo in joint and skin symptoms across biologic naïve and TNF inhibitor-inadequate responder populations.
The new recommendation in axSpA includes patients with active non-radiographic axSpA (nr-axSpA) and objective signs of inflammation who have had an inadequate response or have been intolerant to non-steroidal anti-inflammatory drugs, and those with active ankylosing spondylitis (r-axSpA) who have been inadequately controlled by or been intolerant to conventional therapy. It is recommended only if TNF-alpha inhibitors are not suitable or do not control the condition well enough.
NICE’s decision was based on results from two phase 3 studies in which a greater proportion of axSpA patients treated with Bimzelx, compared with placebo, achieved significant improvement in signs, symptoms and disease activity across the full spectrum of the disease.
Claire Brading, managing director UK and Ireland at UCB, said: “We are proud that [Bimzelx], discovered right here in the UK, has been recommended by NICE for the treatment of axSpA and PsA… We firmly believe that every patient deserves to live as free as possible from the challenges and uncertainty of severe disease, and this recommendation underscores our dedication to supporting people affected by these diseases.”