Rome, June 27. (beraking latest news Salute) – The European Commission has granted a marketing authorization for the monoclonal antibody bimekizumab for the treatment of adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA), including non- radiographic (nr-axSpA) and ankylosing spondylitis (As), also known as radiographic axSpA. This was announced by UCB, a multinational biopharmaceutical company. These EU approvals represent the first marketing authorizations of bimekizumab in PsA and axSpA worldwide, and the second and third indications for bimekizumab in the EU, following approval for bimekizumab. the treatment of moderate to severe plaque psoriasis in August 2021.
“The parallel approval of bimekizumab in PsA and AxSpA by the European Commission – said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of UCB US – builds on the momentum created by its first approval in moderate to plaque psoriasis. severe, and marks an exciting milestone offering healthcare professionals and patients the first IL-17A and IL-17F inhibitor for the treatment of these diseases. The extension of bimekizumab’s approval in the EU reflects our commitment to addressing unmet patient needs, improving patient outcomes and raising standards of care”.
In PsA, bimekizumab is approved alone or in combination with methotrexate for the treatment of adults who have had an inadequate response to or who have been intolerant to one or more antirheumatic drugs (DMARDs). In the axSpA, bimekizumab is approved for the treatment of adults with active nr-axSpA with objective signs of inflammation, indicated by elevated C-reactive protein and/or MRI, who have responded inadequately to or are intolerant to medications non-steroidal anti-inflammatory drugs, and for the treatment of adults with active As, who have responded inadequately or are intolerant to conventional therapy.
The approval of the EC for PsA – details the note – is based on the results of the phase 3 studies Be Optimal and Be Complete. In the two studies, bimekizumab met the primary endpoint of ACR50 response at week 16, compared to placebo, and all secondary endpoints rated. Consistent results were observed in both the biologic-naïve and Tnfi-IR inadequate responder (Tnfi-IR) patient populations. Clinical responses achieved at week 16 were maintained through week 52 in Be Optimal, as assessed by ACR50, PASI90, PASI100, and minimal disease activity (Mda). In Be Optimal, the most frequent treatment-emergent adverse events (3% or more) with bimekizumab up to week 16 were nasopharyngitis, upper respiratory tract infection, headache, diarrhea, oral candidiasis, pharyngitis, and hypertension. In Be Complete, the most frequent adverse events (2% or more) for patients receiving bimekizumab through week 16 were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.
“The approval of bimekizumab in psoriatic arthritis – underlines Iain McInnes of the University of Glasgow, College of Medical, Veterinary and Life Sciences – offers rheumatologists and dermatologists in the EU a new therapeutic option. Data from Phase 3 clinical trials demonstrated the high level of disease control achieved with bimekizumab, compared with placebo, in psoriatic arthritis patients who were biologic-naïve or inadequately responsive to TNF blockers. For Désirée van der Heijde, professor of rheumatology at Leiden University Medical Center, “Today’s approval of a new treatment option for axial spondyloarthritis is welcome news in the European rheumatology community. In Phase 3 clinical trials, a greater proportion of patients treated with bimekizumab than placebo achieved treatment goals, with significant improvement in signs, symptoms and measures of disease activity across the disease spectrum , including non-radiographic and radiographic populations”.
Bimekizumab – specifies the note – is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, and in patients with active clinically important infections (eg active tuberculosis). The drug may increase the risk of infections and its treatment should not be initiated in patients with clinically important active infections. Patients treated with bimekizumab should be instructed to seek medical attention promptly if they develop signs or symptoms suggestive of an infection. If this occurs, they should be closely monitored and if the infection becomes severe or does not respond to standard therapy, treatment should be stopped until the infection has resolved. Serious hypersensitivity reactions, including anaphylactic reactions, have been observed with IL-17 inhibitors. If a severe hypersensitivity reaction occurs, bimekizumab should be discontinued immediately and appropriate therapy initiated. Live vaccines should not be inoculated in patients treated with bimekizumab.
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