UCB Announces European Commission Approval of BIMZELX®▼(bimekizumab) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis

UCB Announces European Commission Approval of BIMZELX^®▼(bimekizumab) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis

• BIMZELX^®▼(bimekizumab) is the first approved treatment for moderate to severe plaque psoriasis that is designed to selectively and directly inhibit both IL-17A and IL-17F 
• The approval in the European Union represents the first marketing authorization for UCB’s new psoriasis treatment worldwide
• Approval is supported by three Phase 3 trials where bimekizumab demonstrated superior levels of skin clearance compared to placebo, ustekinumab and adalimumab, and was generally well-tolerated
• Bimekizumab is a testament to UCB’s commitment to advancing science in immuno-dermatology, addressing unmet needs and improving patient outcomes

Brussels, Belgium – 24th August 2021 – 07:00 CEST - UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted marketing authorization for BIMZELX^® (bimekizumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.  Bimekizumab is the first approved treatment in the European Union (EU) for moderate to severe plaque psoriasis that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.¹

Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections every four weeks to week 16 and every eight weeks thereafter.¹ For some patients with a body weight ≥120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response.¹

“The approval of BIMZELX in Europe is the first marketing authorization for this new psoriasis treatment worldwide and represents a landmark moment for the dermatology community and UCB. Our ambition is to transform the lives of people living with severe diseases, 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 deliver.” 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, recreation, relationships, family and social life.² A cross-sectional patient survey showed at least 90 percent of patients with moderate to severe plaque psoriasis place a high value on treatment which provides clear skin, a sustained response and rapid onset of action.³ In addition, a real-world study showed that gaining completely clear skin can make a meaningful difference to the impact psoriasis has on patients’ health-related quality of life.⁴

“In the pivotal Phase 3 studies patients treated with bimekizumab achieved superior levels of skin clearance compared to those treated with placebo, adalimumab and ustekinumab, and in the Phase 3b study, treatment with bimekizumab resulted in greater levels of skin clearance than secukinumab. Across studies, about 60 percent of bimekizumab-treated patients achieved complete skin clearance at week 16, and this response was maintained for up to a year.” said Professor Richard Warren, Salford Royal NHS Foundation Trust and The University of Manchester, UK. “The approval of bimekizumab in the EU provides a welcome new treatment option that may help more patients with moderate to severe plaque psoriasis to achieve their treatment goals.”

The European Commission approval follows a positive opinion granted in June 2021 by the European Medicines Agency’s Committee for Medicinal Products for Human Use. 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 psoriasis.1 Full findings from the Phase 3 BE READY and BE VIVID studies are published in The Lancet, and the results of the Phase 3 BE SURE study are published in The New England Journal of Medicine.^5,6,7

The approval from the European Commission is valid in all 27 member states of the EU, 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.