UCB Receives Positive CHMP Opinion Recommending Approval of BIMZELX®* (bimekizumab) in the EU for the Treatment of Adults with Moderate to Severe Plaque Psoriasis
The positive CHMP opinion is supported by data from three Phase 3 studies where bimekizumab demonstrated superior levels of skin clearance compared to placebo, ustekinumab and adalimumab
If approved by the European Commission, bimekizumab will be 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 European Commission is expected to deliver its decision on the marketing authorization of bimekizumab, under the trade name BIMZELX®*, in approximately two months
Brussels, Belgium – 25th June, 2021 – 11:00 AM CEST – Regulated Information – Inside Information – UCB, a global biopharmaceutical company, announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending granting a marketing authorization for BIMZELX®* (bimekizumab), an investigational IL-17A and IL-17F inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
“This positive CHMP opinion is a significant regulatory milestone towards approval of bimekizumab in Europe. We’re delighted by today’s decision which recognizes the strength of the psoriasis clinical development program. Bimekizumab is testament to our commitment to advancing science in immuno-dermatology, addressing unmet needs and improving patient outcomes,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.
The positive CHMP opinion is supported by results from three Phase 3 studies – BE VIVID, BE READY and BE SURE – which evaluated the efficacy and safety of bimekizumab in adults with moderate to severe plaque psoriasis.1,2,3 All studies met their co-primary and all ranked secondary endpoints.1,2,3 Patients treated with bimekizumab achieved superior levels of skin clearance (PASI 90 and IGA 0/1**) at week 16 compared to those who received adalimumab, placebo and ustekinumab.1,2,3 Clinical responses achieved with bimekizumab at week 16 were maintained up to one year in all studies.1,2,3 The most frequently reported treatment emergent adverse events in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.1,2,3,
If marketing authorization is granted by the European Commission, bimekizumab will become the first approved treatment for patients with moderate to severe plaque psoriasis in the European Union that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.1,2,3 The positive CHMP opinion is a scientific recommendation which is shared with the European Commission for the adoption of a decision on an EU-wide marketing authorization. A European Commission marketing authorization through the centralized procedure is valid in all European Union Member States, as well as the European Economic Area countries Iceland, Liechtenstein and Norway. UCB is committed to bringing bimekizumab to patients worldwide. Bimekizumab is currently under review by the U.S. Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis. Regulatory reviews are also underway in Japan, Australia and Canada. The efficacy and safety of bimekizumab are also being evaluated in Phase 3 trials in psoriatic arthritis,5,6 ankylosing spondylitis,7 non-radiographic axial spondyloarthritis,8 and hidradenitis suppurativa.9,10