Ucb, a global biopharmaceutical company, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization for Bimzelx® (bimekizumab) , an investigational inhibitor of IL-17A and IL-17F, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. This was reported by a company note. “The positive opinion from the CHMP is a significant milestone towards the approval of bimekizumab in Europe. We are pleased with today’s decision, which recognizes the strength of its clinical development program in treating psoriasis. Bimekizumab testifies to our commitment to advance the science in immunodermatology, addressing unmet needs and improving patient outcomes, ”said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, Ucb. The positive opinion of the CHMP – details the company – is supported by the results of three Phase 3 studies (Be Vivid, Be Ready and Be Sure) that evaluated the efficacy and safety of bimekizumab in adults with plaque psoriasis from moderate to severe. All studies met their primary and all secondary endpoints. Patients treated with bimekizumab achieved higher skin clearance levels at week 16 than those who received adalimumab, placebo and ustekinumab. Clinical responses achieved with bimekizumab at week 16 were maintained for up to one year across all studies. The most frequently reported adverse events in patients treated with bimekizumab were nasopharyngitis, oral candidiasis and upper respiratory tract infection. patients with moderate to severe plaque psoriasis in the EU which is designed to selectively and directly inhibit both IL-17A and IL-17F, two cytokines that play key roles in inflammatory processes. Ucb is committed to making bimekizumab available to patients around the world: it is currently under review by the U.S. Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis. Authorization reviews are also underway in Japan, Australia and Canada. The efficacy and safety of bimekizumab – concludes the note – are also being evaluated in phase 3 studies in psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa.
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