MHRA grants two new marketing authorisations for UCB's inflammatory disease drug

01 Sep 2023
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Clinical ResultDrug ApprovalPhase 3
MHRA grants two new marketing authorisations for UCB's inflammatory disease drug
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Source: PMLiVE
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted UCB's Bimzelx (bimekizumab) two new approvals, with the inflammatory disease drug now authorised to treat certain adults with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).
The marketing authorisations make Bimzelx the first treatment approved for these two patient populations that is designed to inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory disease.
In PsA, a type of arthritis that affects some patients with psoriasis, Bimzelx is now indicated alone or in combination with methotrexate to treat patients with active disease who have had an inadequate response or have been intolerant to one or more disease-modifying antirheumatic drugs.
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 authorisation in axSpA, a type of arthritis that mainly affects the joints of the spine, 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.
The MHRA’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 the approvals marked a "significant milestone for the rheumatology community in the UK”.
She continued: "We are extremely proud to be able to bring a new dual action biological treatment option to a broad range of people living with PsA and axSpA in the UK."
Professor Karl Gaffney, consultant rheumatologist at the Norfolk and Norwich University Hospital NHS Foundation Trust, said: “The unfortunate reality for many patients is that they will have to cycle through a number of treatments before eventually finding one that works for them.
“I welcome the possibility of a new, dual-action, biologic treatment option to potentially improve the quality of life of people living with PsA and axSpA.”
MHRA grants two new marketing authorisations for UCB's inflammatory disease drug
Preview
Source: PMLiVE
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