The global biopharmaceutical company, Ucb, announced that the European Commission “has granted marketing authorization for bimekizumab for the treatment of moderate to severe plaque psoriasis in adult candidates for systemic therapy,” the company said. “Bimekizumab is the first approved treatment in the European Union for moderate to severe plaque psoriasis, designed to selectively and directly inhibit both IL-17A and IL-17F, two cytokines that play a key role in inflammatory processes,” continues the Note.
“Bimekizumab is approved at the recommended dose of 320 mg, given as two subcutaneous injections every four weeks through week 16 and every eight weeks thereafter. For some patients with a body weight above 120 kg who have not achieved complete skin clearance per week 16, 320 mg of bimekizumab every 4 weeks after week 16 may further improve treatment response, “Ucb points out.
“The approval of bimekizumab in Europe is the first marketing authorization of this new treatment for psoriasis worldwide and represents a historic moment for the dermatology community and for UCB. Our ambition is to transform the lives of the people who living with severe illness, and we are incredibly proud to bring a new treatment option to people living with moderate to severe plaque psoriasis in Europe. We believe that bimekizumab has the potential to raise expectations of what psoriasis treatment can offer, “said Emmanuel Caeymaex, executive vice president, Immunology Solutions and Head of US, Ucb.
Psoriasis can have a considerable physical and psychological impact on patients, as well as being detrimental to their quality of life, potentially affecting work, recreational activities, relationships, family and social life. “A cross-sectional survey of patients showed that at least 90% of patients with moderate to severe plaque psoriasis place a high value on treatment that ensures ‘clean’ skin, a lasting response and a quick onset of action. In addition, a real-world study has shown that obtaining completely ‘clean’ skin can make a significant difference in the impact that psoriasis has on patients’ health-related quality of life “.
“In the pivotal phase 3 studies, patients treated with bimekizumab achieved higher levels of skin clearance than those treated with placebo, adalimumab and ustekinumab and, in the phase 3b study, treatment with bimekizumab resulted in higher levels of skin clearance compared to secukinumab. In all studies, approximately 60% of patients treated with bimekizumab achieved complete skin clearance at week 16 and this response was maintained for up to one year, “explained Richard Warren, Salford Royal NHS Foundation Trust. and The University of Manchester. “The approval of bimekizumab in the EU provides a new treatment option that can help more patients with moderate to severe plaque psoriasis reach their treatment goals.”
The European ok follows a positive opinion granted in June 2021 by the CHMP of the European Medicines Agency (EMA). The approval is supported by positive results from three Phase 3 studies, which evaluated the efficacy and safety of bimekizumab in 1,480 patients with moderate to severe plaque psoriasis1. The full results of the phase 3 studies, ‘Be ready and Be vivid’, are published in the ‘Lancet’, and the results of the phase 3 study, ‘Be sure’, are published in ‘The New England Journal of Medicine’. The approval is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Bimekizumab is currently under review by the U.S. Food & Drug Administration (FDA) for the treatment of adults with moderate to severe plaque psoriasis. Regulatory reviews are also underway in Australia, Canada, Great Britain and Japan.