UCB secures registration of rheumatology drug

Pharma News: UCB Australia has secured Therapeutic Goods Administration (TGA) approval of its therapy for psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). Bimzelx (bimekizumab) was reviewed during the March PBAC for Pharmaceutical Benefits Scheme (PBS) reimbursement.

Bimzelx is a monoclonal antibody that selectively inhibits IL-17A and IL-17F, two key cytokines that play a hand in the inflammatory process.

Professor Stephen Hall, rheumatologist at the Cabrini Medical Centre, said “Having been involved in the bimekizumab clinical trial program, I am looking forward to the opportunity to prescribe bimekizumab in the real world for this expanded group of patients.

“Adults living with psoriatic arthritis and axial spondyloarthritis often experience a range of severe symptoms affecting their quality of life, including swollen and stiff joints, chronic pain and irreversible structural damage. The TGA registration of Bimzelx potentially provides a valuable new treatment option for patients.”

A review published in January 2024 assessed Bimzelx’s performance against other available psoriasis and PsA treatments.

“The results demonstrated the favourable relative efficacy and safety of bimekizumab 160 mg Q4W vs all approved treatments for PsA. Bimekizumab ranked high in terms of efficacy on joint, skin and minimal disease activity (MDA) outcomes in both b/tsDMARD-naïve and TNFi-experienced patient populations, and showed comparable safety to other treatments.”

Francesca Bianco, Immunology PVU Head at UCB Australia, said “Our ambition at UCB is to transform the lives of people living with severe diseases. We are pleased to bring a new treatment option to healthcare professionals and people living with psoriatic arthritis and axial spondyloarthritis in Australia.”

This approval follows the TGA registration of Bimzelx in March 2022 for treating moderate to severe plaque psoriasis in adult patients eligible for systemic therapy or phototherapy.

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