UCB (EBR:UCB) BIMZELX® (bimekizumab) Receives Approval in Japan for the Treatment of Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis and Ankylosing Spondylitis

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27/12/2023 07:01
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6elFAkTlNf9IRjfBprWAH-2BoSMH0AUOFDMRvrkbihvX-2F5t0iQMiPP= 5ZY2iYlZidSB36hw405CYeyNJ2tBe4rk3lpDOiVp_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVW= u7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19e= cNE7nFy8buOLD3011XKEBm5XlxgihIWov8LLIWj4b4iR9qSmoqQ1bPTPP-2BLiQmRDbGKXNv5dB= oNfUDc3Ga8nPN7EBoMOEmsLC8rg1Ky8Ugkfp3-2BXiwyjx1RnsuG7lSji9VHDM-2B8y8UJZ6iRk= GQfiaGcWLUfTToy0HRqVg8dPD5lC-2FVAbGUuLm7utbZi-2BDbdga1L3EuV-2FqViUJC4iNbCjZ= EmMAK8NPjgFBmadTzFT08dmfrE8saupz9JrUVMwTLL-2Bq-2BY-2BVQ-3D ** BIMZELX^=C2=AE (bimekizumab) Receives Approval in Japan for the Treatmen= t of Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis and Anky= losing Spondylitis ------------------------------------------------------------ =C2=B7 Bimekizumab is the first IL-17A and IL-17F inhibitor to receive regu= latory approval in Japan for the treatment of psoriatic arthritis (PsA), no= n-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondyliti= s (AS) in adult patients =C2=B7 The extended approval for bimekizumab in Japan follows its first app= roval in January 2022 for plaque psoriasis, generalized pustular psoriasis,= and psoriatic erythroderma=C2=A0 =C2=B7 This represents the third approval by regulatory authorities around = the world for bimekizumab in PsA, nr-axSpA and AS=C2=A0 Brussels (Belgium), 27th December 2023 =E2=80=93 07:00 (CET) =E2=80=93 UCB,= a global biopharmaceutical company, today announced that the Japanese Mini= stry of Health, Labour and Welfare (MHLW) has approved BIMZELX^=C2=AE (bime= kizumab) for the treatment of adults with psoriatic arthritis (PsA), non-ra= diographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) who are not suf= ficiently responding to existing treatments.^1 The new indications for bime= kizumab in Japan follow its first approval in January 2022 for the treatmen= t of plaque psoriasis, generalized pustular psoriasis, and psoriatic erythr= oderma.^1 Bimekizumab is the first IL-17A and IL-17F inhibitor to receive r= egulatory approval in Japan for the treatment of PsA, nr-axSpA and AS in ad= ult patients. This milestone also represents the third approval for bimekiz= umab in PsA, nr-axSpA and AS in 2023, following approval for these addition= al indications in countries of the European Union/European Economic Area an= d in Great Britain in June and August 2023, respectively.^2,3 =E2=80=9CWe are excited to bring bimekizumab as a new treatment option for = people in Japan living with psoriatic arthritis and those living with axial= spondyloarthritis. The extended approval for bimekizumab in Japan beyond t= he psoriasis indications expands the reach of the first dual IL-17A and IL-= 17F inhibitor and marks another step forward in our ambition to transform l= ives,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology= Solutions and Head of U.S., UCB. Bimekizumab was approved in Japan for the treatment of adult patients with = PsA. The approval is based on data from the Phase 3 BE COMPLETE and BE OPTI= MAL studies published as back-to-back manuscripts in The Lancet.^4,5=C2=A0B= imekizumab was also approved in Japan for the treatment of adult patients w= ith ankylosing spondylitis and non-radiographic axial spondyloarthritis. Th= e approval is based on data from the Phase 3 BE MOBILE 1 and BE MOBILE 2 st= udies, published in Annals of the Rheumatic Diseases.^6 The safety profile = of bimekizumab in all four studies was consistent with safety data seen in = previous studies with no new observed safety signals.^4,5,6 UCB is committed to bringing bimekizumab to patients with PsA and axSpA wor= ldwide. Regulatory reviews are underway in other countries including Austra= lia, Canada, Switzerland and China (axSpA only). Notes to editors: About Psoriatic Arthritis Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, syst= emic inflammatory condition affecting both the joints and skin, with a prev= alence of 0.02 percent to 0.25 percent of the population, and 6 percent to = 41 percent of patients with psoriasis. =C2=A0Symptoms include joint pain an= d stiffness, skin plaques, swollen toes and fingers (dactylitis) and inflam= mation of the sites where tendons or ligaments insert into the bone (enthes= itis).^8 About Axial Spondyloarthritis Axial spondyloarthritis (axSpA), which includes both non-radiographic axSpA= (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axS= pA (r-axSpA), is a chronic, immune-mediated, inflammatory disease.^9 nr-axS= pA is defined clinically by the absence of definitive x-ray evidence of str= uctural damage to the sacroiliac joints.^9 axSpA is a painful condition tha= t primarily affects the spine and the joints linking the pelvis and lower s= pine (sacroiliac joints).^9 The leading symptom of axSpA in a majority of p= atients is inflammatory back pain that improves with exercise but not with = rest.^9 Other common clinical features frequently include anterior uveitis,= enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease an= d dactylitis.^9 The overall prevalence of axSpA is 0.3 percent to 1.3 perce= nt of adults.^10,11=C2=A0 Approximately half of all patients with axSpA are= patients with nr-axSpA.^9 axSpA onset usually occurs before the age of 45.= 9 Approximately 10 to 40 percent of patients with nr-axSpA progress to AS o= ver 2 to 10 years.^9 About BE OPTIMAL and BE COMPLETE The safety and efficacy of bimekizumab (160 mg every four weeks) were evalu= ated in adult patients with active psoriatic arthritis (PsA) in two phase 3= multicentre, randomized, double-blind, placebo-controlled studies (BE OPTI= MAL and BE COMPLETE).^4,5 The BE OPTIMAL study evaluated 852 patients not p= reviously exposed to any biologic disease-modifying anti-rheumatic drug (bD= MARD-na=C3=AFve) for the treatment of active psoriatic arthritis.^4 The BE = COMPLETE study evaluated 400 patients with an inadequate response or intole= rance to treatment with one or two tumour necrosis factor-alpha inhibitors = (TNFi-IR) for active psoriatic arthritis.^5 Detailed findings from the BE O= PTIMAL and BE COMPLETE studies are published in The Lancet.^4,5 About BE MOBILE 1 and BE MOBILE 2=C2=A0 The efficacy and safety of bimekizumab (160 mg every four weeks) were evalu= ated in 586 adult patients with active axial spondyloarthritis (axSpA) in t= wo phase 3 multicenter, randomized, double-blind, placebo-controlled studie= s, one in non-radiographic axSpA (nr-axSpA; BE MOBILE 1) and one in ankylos= ing spondylitis (AS; BE MOBILE 2), also known as radiographic axSpA.^6 The = BE MOBILE 1 and BE MOBILE 2 studies evaluated 254 and 332 patients, respect= ively.^6 Detailed findings from the BE MOBILE 1 and BE MOBILE 2 studies are= published in the Annals of the Rheumatic Diseases.^6 About bimekizumab =E2=96=BC=C2=A0in the EU Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel= ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)= , two key cytokines driving inflammatory processes. =C2=A0The therapeutic i= ndications in the European Union are: =C2=B7 Plaque psoriasis: Bimekizumab is indicated for the treatment of mode= rate to severe plaque psoriasis in adults who are candidates for systemic t= herapy.^2=C2=A0 =C2=B7 Psoriatic arthritis: Bimekizumab, alone or in combination with metho= trexate, is indicated for the treatment of active psoriatic arthritis in ad= ults who have had an inadequate response or who have been intolerant to one= or more disease-modifying antirheumatic drugs (DMARDs).^2 =C2=B7 Axial Spondyloarthritis: Bimekizumab is indicated for the treatment = of adults with active non-radiographic axial spondyloarthritis with objecti= ve signs of inflammation as indicated by elevated C-reactive protein (CRP) = and/or magnetic resonance imaging (MRI) who have responded inadequately or = are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs) and for th= e treatment of adults with active ankylosing spondylitis who have responded= inadequately or are intolerant to conventional therapy.^2 BIMZELX^=C2=AE =E2=96=BC (bimekizumab) EU/EEA* Important Safety Information= ^2 The most frequently reported adverse reactions with bimekizumab were upper = respiratory tract infections (14.5%, 14.6%, 16.3% in plaque psoriasis (PSO)= , psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), respective= ly) and oral candidiasis (7.3%, 2.3%, 3.7% in PSO, PsA and axSpA, respectiv= ely). Common adverse reactions (=E2=89=A51/100 to <1/10) were oral candidia= sis, tinea infections, ear infections, Herpes simplex infections, oropharyn= geal candidiasis, gastroenteritis, folliculitis, headache, rash, dermatitis= and eczema, acne, injection site reactions, fatigue. Elderly may be more l= ikely to experience certain adverse reactions such as oral candidiasis, der= matitis and eczema when using bimekizumab. Bimekizumab is contraindicated in patients with hypersensitivity to the act= ive substance or any of the excipients and in patients with clinically impo= rtant active infections (e.g. active tuberculosis). Bimekizumab may increase the risk of infections. Treatment with bimekizumab= must not be initiated in patients with any clinically important active inf= ection. Patients treated with bimekizumab should be instructed to seek medi= cal advice if signs or symptoms suggestive of an infection occur. If a pati= ent develops an infection the patient should be carefully monitored. If the= infection becomes serious or is not responding to standard therapy, treatm= ent should be discontinued until the infection resolves. Prior to initiatin= g treatment with bimekizumab, patients should be evaluated for tuberculosis= (TB) infection. Bimekizumab should not be given in patients with active TB= . Patients receiving bimekizumab should be monitored for signs and symptoms= of active TB. Cases of new or exacerbations of inflammatory bowel disease have been repor= ted with bimekizumab. Bimekizumab is not recommended in patients with infla= mmatory bowel disease. If a patient develops signs and symptoms of inflamma= tory bowel disease or experiences an exacerbation of pre-existing inflammat= ory bowel disease, bimekizumab should be discontinued and appropriate medic= al management should be initiated. Serious hypersensitivity reactions including anaphylactic reactions have be= en observed with IL-17 inhibitors. If a serious hypersensitivity reaction o= ccurs, administration of bimekizumab should be discontinued immediately and= appropriate therapy initiated. Live vaccines should not be given in patients treated with bimekizumab. Please consult the Summary of Product Characteristics in relation to other = side effects, full safety and prescribing information. European SmPC date of revision: November 2023.=C2=A0 https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3E= U-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH6uJI6dDXHRika= HhL8HIZVsPc5Q6uIhYECs-2Fl2G-2Bmd0FHEEN1rJ7-2FbHVsMI0nMnjAQ-3D-3DLkbb_xDPID0= vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2Bf= Psk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5XlxgihIWov8LLIWj4b4iR9qS= moqQ1bPTPP-2BLiQmRDbGKXNv5dBoNfUDc3Ga8nPN7EBoMOEmsLC8rg1Ky8Ugkfp3-2BXtxj-2F= m-2FdEPSvzqwQnXcUpjvg88uGC4No-2Fjp5EhvKrcZmsoqC6oWUthLaQr6j4FAM4RU5jwh1WLDR= X73WxRUJW2CrNlKE6zShsAkXCy4-2FDLrrFxmDhNw6pag-2F2gvWR6FqihwaR-2FmnncEbboyP1= Tb2TJg-3D Last Accessed: December 2023 *EU/EEA: European Union/European Economic Area =E2=96=BC=C2=A0 This medicinal product is subject to additional monitoring.= This will allow quick identification of new safety information. Healthcare= professionals are asked to report any suspected adverse reactions. For further information, contact UCB:=C2=A0 Investor Relations Antje Witte T +32.2.559.94.14=C2=A0 email antje.witte@ucb.com=C2=A0 Corporate Communications Laurent Schots=C2=A0 T +32.2.559.92.64=C2=A0 email laurent.schots@ucb.com Brand Communications Eimear O=E2=80=99Brien T +32.2.559.92.71 email eimear.obrien@ucb.com=C2=A0 About UCB=C2=A0 UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With approximately 8,700 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. 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Available at: https://u7061146.ct.= sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUc8WVK0-2FE-2FQTozpsM-2Fg= 7fzcyxp0msekY8-2B21IQeRydaoznNdLNxUuN-2BK8OVc2e7jmYv7LWhy4TUt268AnTwYmJo-3D= 90Fy_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic= -2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5XlxgihIWov8LL= IWj4b4iR9qSmoqQ1bPTPP-2BLiQmRDbGKXNv5dBoNfUDc3Ga8nPN7EBoMOEmsLC8rg1Ky8Ugkfp= 3-2BXmNgcOmbSr4lYDHgoMaabcttTDuVMq3q9LHti7MdyFpbKNSQ9fI8wy24D5RN8d8aRi-2Bli= ybq4OuuRO0fshmf6dbK6FQDL9znJztpfT-2B69TM65I2pDWGvrQu5Q-2BzjrPfhSSRQ22lKYLEX= Qt3xByvOaGA-3D Last accessed: December 2023. 4. McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with ps= oriatic arthritis, na=C3=AFve to biologic treatment: a randomised, double-b= lind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(1037= 0):25=E2=80=9337. 5. Merola JF, Landew=C3=A9 R, McInnes IB, et al. 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