UCB (EBR:UCB) UCB Media Room: EMA Accepts Marketing Authorization Applications for Bimekizumab in Psoriatic Arthritis and Axial Spondyloarthritis

Directive transparence : information réglementée

20/09/2022 07:14
https://mb.cision.com/Public/18595/3633521/9ede195250bc24e5_800x800ar.png ** European Medicine Agency Accepts Marketing Authorization Applications fo= r Bimekizumab in Psoriatic Arthritis and Axial Spondyloarthritis ------------------------------------------------------------ =C2=B7 First regulatory submissions for bimekizumab in psoriatic arthritis = and axial spondyloarthritis worldwide Brussels (Belgium), 20th September 2022 =E2=80=93 07:00 (CEST) =E2=80=93 UC= B, a global biopharmaceutical company, today announced that the European Me= dicines Agency (EMA) has accepted for regulatory review the two marketing a= uthorization applications for bimekizumab for the treatment of adult patien= ts with active psoriatic arthritis (PsA), and adult patients with active ax= ial spondyloarthritis (axSpA). =E2=80=9CThese two regulatory applications in psoriatic arthritis and axial= spondyloarthritis represent a significant milestone for bimekizumab as wel= l as an important step towards expanding treatment options in the EU for th= ese debilitating conditions. If approved for these two new indications, bim= ekizumab would be the first new treatment option in psoriatic arthritis and= axial spondyloarthritis to selectively target IL-17F, in addition to IL-17= A,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology So= lutions and Head of U.S., UCB. The application in PsA is supported by data from the Phase 3 BE OPTIMAL and= BE COMPLETE studies.^1,2=C2=A0 In both studies, bimekizumab met the primar= y and all ranked secondary endpoints, achieving clinically relevant improve= ments over placebo in both joint and skin symptoms, with efficacy outcomes = consistent across the biologic-na=C3=AFve and TNF-inhibitor inadequate resp= onder (TNFi-IR) populations.^1,2 The application in active axSpA is based o= n data from the Phase 3 BE MOBILE 1 study in non-radiographic axSpA and the= Phase 3 BE MOBILE 2 study in ankylosing spondylitis.^3,4=C2=A0 Bimekizumab= met the primary and all ranked secondary endpoints in both studies showing= consistent improvements versus placebo in signs and symptoms across the fu= ll spectrum of axSpA, including non-radiographic axSpA and ankylosing spond= ylitis.3,4 Across all four Phase 3 studies the safety profile of bimekizuma= b was consistent with safety data seen in previous studies with no new obse= rved safety signals.^1,2,3,4=C2=A0 In August 2021, bimekizumab received marketing authorization in countries o= f the European Union (EU)/European Economic Area (EEA) for the treatment of= moderate to severe plaque psoriasis in adults who are candidates for syste= mic therapy.^5 The safety and efficacy of bimekizumab in PsA and axSpA have= not been established, and it is not approved for use in PsA or axSpA by an= y regulatory authority worldwide. 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.^6 Symptoms include joint pain and st= iffness, skin plaques, swollen toes and fingers (dactylitis), and inflammat= ion of the sites where tendons or ligaments insert into the bone (enthesiti= s).^7 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.^8 nr-axS= pA is defined clinically by the absence of definitive x-ray evidence of str= uctural damage to the sacroiliac joints.^8 AxSpA is a painful condition tha= t primarily affects the spine and joints linking the pelvis and lower spine= (sacroiliac joints).^8 The leading symptom of axSpA in the majority of pat= ients is inflammatory back pain that improves with exercise, but not with r= est.^8 Other common clinical features include anterior uveitis, enthesitis,= peripheral arthritis, psoriasis, inflammatory bowel disease and dactylitis= .^8 The overall prevalence of axSpA is 0.3 percent to 1.3 percent of adults= .^9,10 Approximately half of all patients with axSpA are patients with nr-a= xSpA.8 axSpA onset usually occurs before the age of 45.8 Approximately 10 t= o 40 percent of patients with nr-axSpA progress to ankylosing spondylitis o= ver 2 to 10 years.^8 About BE OPTIMAL BE OPTIMAL is a randomized, multicenter, double-blind, placebo-controlled, = active reference (adalimumab), parallel-group, Phase 3 study designed to ev= aluate the efficacy and safety of bimekizumab in the treatment of adult pat= ients with active PsA, who are biologic disease-modifying anti rheumatic dr= ug na=C3=AFve. For additional details on the study, visit BE OPTIMAL on cli= nicaltrials.gov (https://www.clinicaltrials.gov/ct2/show/NCT03895203?term= =3DBE+OPTIMAL&draw=3D2&rank=3D1) .^11 About BE COMPLETE BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled= , parallel-group, Phase 3 study designed to evaluate the efficacy and safet= y of bimekizumab in adults with active PsA and an inadequate response to tu= mor necrosis factor inhibitors (TNFi-IR).^12 All enrolled study participant= s had a history of inadequate response (lack of efficacy after at least thr= ee months of therapy at an approved dose) or intolerance to treatment with = one or two TNFi for either PsA or psoriasis. For additional details on the = study, visit BE COMPLETE on clinicaltrials.gov (https://www.clinicaltrials.= gov/ct2/show/NCT03896581) .^12 About BE MOBILE 1 =C2=A0 =C2=A0 BE MOBILE 1 is a randomized, multicenter, double-blind, placebo-controlled,= parallel-group, Phase 3 study designed to evaluate the efficacy and safety= of bimekizumab in the treatment of adult patients with active nr-axSpA. Fo= r additional details on the study, visit BE MOBILE 1 on clinicaltrials.gov = (https://clinicaltrials.gov/ct2/show/NCT03928704) .^13 About BE MOBILE 2 BE MOBILE 2 is a randomized, multicenter, double-blind, placebo-controlled,= parallel-group, Phase 3 study designed to evaluate the efficacy and safety= of bimekizumab in the treatment of adult patients with active AS. For addi= tional details on the study, visit BE MOBILE 2 on clinicaltrials.gov (https= ://www.clinicaltrials.gov/ct2/show/NCT03928743) .^14 About BIMZELX^=C2=AE=E2=96=BC(bimekizumab) BIMZELX=C2=AE (bimekizumab) is a humanized monoclonal IgG1 antibody that is= designed to selectively inhibit both interleukin 17A (IL-17A) and interleu= kin 17F (IL-17F), two key cytokines driving inflammatory processes.^5,15 In= August 2021, bimekizumab was approved in the EU/EEA and Great Britain for = the treatment of moderate to severe plaque psoriasis in adults who are cand= idates for systemic therapy.^5,16=C2=A0 In January 2022, bimekizumab receiv= ed marketing authorization in Japan for the treatment of plaque psoriasis, = generalized pustular psoriasis and psoriatic erythroderma in patients who a= re not sufficiently responding to existing treatments.^17=C2=A0 In February= and March 2022, bimekizumab received marketing authorization in Canada and= Australia respectively for the treatment of moderate to severe plaque psor= iasis in adults who are candidates for systemic therapy or phototherapy.^18= ,19 BIMZELX^=C2=AE =C2=A0=E2=96=BC (bimekizumab) EU/EEA Important Safety Inform= ation in Psoriasis The most frequently reported adverse reactions with bimekizumab were upper = respiratory tract infections (14.5 percent) (most frequently nasopharyngiti= s) and oral candidiasis (7.3 percent). Common adverse reactions (=E2=89=A51= /100 to <1/10) were oral candidiasis, tinea infections, ear infections, her= pes simplex infections, oropharyngeal candidiasis, gastroenteritis, follicu= litis, headache, dermatitis and eczema, acne, injection site reactions, fat= igue. Elderly may be more likely to experience certain adverse reactions su= ch as oral candidiasis, dermatitis 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).=C2=A0 Bimekizumab may increase the risk of infections. Treatment with bimekizumab= must not be administered in patients with any clinically important active = infection. Patients treated with bimekizumab should be instructed to seek m= edical advice if signs or symptoms suggestive of an infection occur. Prior = to initiating treatment with bimekizumab, patients should be evaluated for = tuberculosis (TB) infection. Bimekizumab should not be given in patients wi= th active TB and patients receiving bimekizumab should be monitored for sig= ns and symptoms of active TB.=C2=A0 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 inclu= ding anaphylactic reactions have been observed with IL-17 inhibitors. If a = serious hypersensitivity reaction occurs, administration of bimekizumab sho= uld be discontinued immediately and appropriate therapy initiated.=C2=A0 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. https://www.ema.euro= pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.= pdf EU summary of product characteristics date of revision March 2022 Last accessed: June 2022 =E2=96=BC=C2=A0This 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=C2=A0 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=C2=A0 =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 8,600 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. 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Bimeki= zumab in bDMARD-Na=C3=AFve Patients with Psoriatic Arthritis: 24-Week Effic= acy & Safety from BE OPTIMAL, a Phase 3, Multicentre, Randomised, Placebo-C= ontrolled, Active Reference Study. Abstract no: 5016. Presented at EULAR 20= 22. 2.=C2=A0=C2=A0 =C2=A0Merola JF, Mcinnes I, Ritchlin CT et al. Bimekizumab i= n Patients with Active Psoriatic Arthritis and an Inadequate Response to Tu= mour Necrosis Factor Inhibitors: 16-Week Efficacy & Safety from BE COMPLETE= , a Phase 3, Multicentre, Randomised Placebo-Controlled Study. Abstract no:= 2265. Presented at EULAR 2022. 3.=C2=A0=C2=A0 =C2=A0Deodhar A, van der Heijde D, Gensler LS et al. Bimekiz= umab in patients with active non-radiographic axial spondyloarthritis: 24-w= eek efficacy and safety from BE MOBILE 1, a phase 3, multicentre, randomise= d, placebo-controlled study. Abstract no: POS 0939. Presented at EULAR 2022= . 4.=C2=A0=C2=A0 =C2=A0van der Heijde D, Baraliakos X, Dougados M et al. Bime= kizumab in patients with active ankylosing spondylitis: 24-week efficacy an= d safety from BE MOBILE 2, a phase 3, multicentre, randomised, placebo-cont= rolled study. Abstract no: OP0019. Presented at EULAR 2022. 5.=C2=A0=C2=A0 =C2=A0BIMZELX=C2=AE (bimekizumab) EU Summary of Product Char= acteristics. =C2=A0 https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-pro= duct-information_en.pdf. Last accessed: September 2022. 6.=C2=A0=C2=A0 =C2=A0Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthri= tis. Rheum Dis Clin North Am. 2015; 41(4): 545=E2=80=93568. 7.=C2=A0=C2=A0 =C2=A0Mease PJ, Armstrong AW. Managing patients with psoriat= ic disease: the diagnosis and pharmacologic treatment of psoriatic arthriti= s in patients with psoriasis. Drugs. 2014; 74:423-441. 8.=C2=A0=C2=A0 =C2=A0Deodhar A. Understanding Axial Spondyloarthritis: A Pr= imer for Managed Care. Am J Manag Care. 2019;25:S319-S330. 9.=C2=A0=C2=A0 =C2=A0Reveille J, Witter J, Weisman M. Prevalence of axial s= pondylarthritis in the United States: estimates from a cross-sectional surv= ey. Arthritis Care Res. 2012;64(6):905-910. 10.=C2=A0=C2=A0 =C2=A0Hamilton L, Macgregor A, Toms A, et al. The prevalenc= e of axial spondyloarthritis in the UK: a cross-sectional cohort study. BMC= Musculoskelet Disord. 2015;21(16):392. 11.=C2=A0=C2=A0 =C2=A0ClinicalTrials.gov. A Study to Test the Efficacy and = Safety of Bimekizumab in the Treatment of Subjects with Active Psoriatic Ar= thritis (BE OPTIMAL). Available at: https://www.clinicaltrials.gov/ct2/show= /NCT03895203?term=3DBE+OPTIMAL&draw=3D2&rank=3D1 Last accessed: September 2= 022. 12.=C2=A0=C2=A0 =C2=A0ClinicalTrials.gov. A Study to Evaluate the Efficacy = and Safety of Bimekizumab in the Treatment of Subjects with Active Psoriati= c Arthritis (BE COMPLETE). Available at: https://www.clinicaltrials.gov/ct2= /show/NCT03896581 Last accessed: September 2022. 13.=C2=A0=C2=A0 =C2=A0ClinicalTrials.gov. A Study to Evaluate the Efficacy = and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spo= ndyloarthritis (BE MOBILE 1). Available at: https://clinicaltrials.gov/ct2/= show/NCT03928704. =C2=A0Last accessed: September 2022. 14.=C2=A0=C2=A0 =C2=A0ClinicalTrials.gov. A Study to Evaluate the Efficacy = and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis (B= E MOBILE 2). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03928= 743. Last accessed: September 2022. 15.=C2=A0=C2=A0 =C2=A0Glatt S, Helmer E, Haier B, et al. First-in-human ran= domized study of bimekizumab, a humanized monoclonal antibody and selective= dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmaco= l. 2017;83(5):991-1001. 16.=C2=A0=C2=A0 =C2=A0BIMZELX=C2=AE (bimekizumab) GB Summary of Product Cha= racteristics.=C2=A0 https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.u= k/emc/product/12833. Last accessed: September 2022. 17.=C2=A0=C2=A0 =C2=A0Pharmaceuticals and Medical Devices Agency https://ww= w.pmda.go.jp/english/review-services/reviews/approved-information/drugs/000= 1.html. Last accessed: August 2022. 18.=C2=A0=C2=A0 =C2=A0BIMZELX (bimekizumab) Canada Product Monograph. Avail= able at: https://pdf.hres.ca/dpd_pm/00064702.PDF. Last accessed: September = 2022. 19.=C2=A0=C2=A0 =C2=A0BIMZELX (bimekizumab) Australia. Available at: https:= //www.tga.gov.au/apm-summary/bimzelx. Last accessed: September 2022. =C2=A0 GenericFile GL-N-BK-axSpA-2200065 FINAL (https://mb.cision.com/Public/18595/3633521/a9a= 411734695f8e7.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x116286x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium