UCB (EBR:UCB) UCB Media Room: European Commission approval for BIMZELX®▼(bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe HS

Transparency directive : regulatory news

22/04/2024 07:01

https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC= rjYrJUHPDVbu1NKaBE-3DxxLN_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33EIfh7JrrTBvNRLtG5Nps6v-2BaYlDVNGRj5fP6ozk7SdypmAJOSEPkCILZg9I= TTRY91v0NDW49ovP012aIx4QV7b-2B6NymX7Y8t2jyS9RCCJKKx2SES711KCINj6T3xru7s2Wle= cA5Suop4dzURZDtIjGmLnEvZHU4TxtSVfo-2B1Pdr9xOdRQUeGMdtNP0D-2BkUP5ie22jHtawpe= 6bbti266Jyrhz7FihyZpaxXwnre9VVdI-3D ** UCB receives European Commission approval for BIMZELX^=C2=AE=E2=96=BC(bi= mekizumab) as the first IL-17A and IL-17F biologic for moderate to severe h= idradenitis suppurativa ------------------------------------------------------------ =C2=B7 Marketing authorization in the European Union (EU) represents the fi= rst regulatory approval worldwide for bimekizumab in the treatment of moder= ate to severe hidradenitis suppurativa, and its fourth approved indication = within the EU =C2=B7 Approval is supported by data from two Phase 3 studies, BE HEARD I a= nd BE HEARD II, in which bimekizumab significantly improved the signs of di= sease compared with placebo at Week 16, which were sustained to Week 48, an= d was well-tolerated=C2=A0 =C2=B7 Hidradenitis suppurativa is a chronic, relapsing and painful inflamm= atory skin disease with a significant unmet clinical need for which there a= re few approved treatment options Brussels (Belgium), 22 April 2024 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a gl= obal biopharmaceutical company, today announced that the European Commissio= n (EC) has granted marketing authorization for BIMZELX^=C2=AE (bimekizumab)= for the treatment of active moderate to severe hidradenitis suppurativa (H= S) in adults with an inadequate response to conventional systemic HS therap= y.^1 The approval follows a positive opinion issued in March 2024 by the Co= mmittee for Medicinal Products for Human Use of the European Medicines Agen= cy. The EC approval was granted based on results from two Phase 3 studies, = BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bime= kizumab in the treatment of moderate to severe HS.=C2=A0 =E2=80=9CThe European Commission=E2=80=99s approval of bimekizumab marks a = significant milestone for the EU hidradenitis suppurativa community, partic= ularly considering the limited treatment options currently available,=E2=80= =9D said Prof. Dr. Christos C. Zouboulis, President of the European Hidrade= nitis Suppurativa Foundation (EHSF) e.V. and Director of the Departments of= Dermatology, Venereology, Allergology and Immunology, St=C3=A4dtisches Kli= nikum Dessau, Brandenburg Medical School, Germany. =E2=80=9CAs a community,= we strive to improve the management of hidradenitis suppurativa. Bimekizum= ab offers a promising new therapeutic option for moderate to severe disease= , supported by Phase 3 evidence that demonstrated clinically meaningful and= sustained responses over 48 weeks.=E2=80=9D=C2=A0 HS is a chronic, relapsing inflammatory skin disease that manifests as nodu= les, abscesses and pus-discharging fistulas, i.e., channels leading out of = the skin, typically in the armpits, groin, and buttocks.^2,3=C2=A0 HS typic= ally starts in early adulthood and affects approximately one percent of the= population in most studied countries.^2,3 HS is associated with significan= t co-morbidities and can have a profound negative effect on patients=E2=80= =99 quality of life.^2,3=C2=A0 =E2=80=9CHidradenitis suppurativa can have a devastating impact on people, = especially those with moderate to severe disease. In addition to the physic= al symptoms, there can also be a considerable psychological burden for many= people, resulting in a reduced quality of life and missing out on importan= t life events,=E2=80=9D said Barry McGrath, Ph.D., Co-Founder of HS Ireland= , an association for all people affected by hidradenitis suppurativa in Ire= land. =E2=80=9CThe possibility of a new treatment option to help people liv= ing with this disease is most welcome.=E2=80=9D =E2=80=9CWe are proud to bring the first and only approved medicine targeti= ng IL-17A and IL-17F to the hidradenitis suppurativa community. We believe = that bimekizumab has the potential to transform care for people living with= moderate to severe disease,=E2=80=9D said Emmanuel Caeymaex, Executive Vic= e President, Immunology Solutions and Head of U.S. =E2=80=9CToday=E2=80=99s= approval signifies the expansion of bimekizumab to its fourth approved ind= ication within the European Union. This milestone achievement underscores o= ur unwavering commitment to raising standards of care across a spectrum of = IL-17 mediated diseases.=E2=80=9D Notes to editors: About BE HEARD I and BE HEARD II^1 BE HEARD I and BE HEARD II were multicenter, randomized, double-blind, plac= ebo-controlled Phase 3 studies designed to evaluate the efficacy and safety= of bimekizumab in adults with moderate to severe hidradenitis suppurativa = (HS). The two studies had a combined enrolment of 1,014 adult patients with= a diagnosis of moderate to severe HS. The primary endpoint in both studies= was HiSCR50 at Week 16. A key secondary endpoint was HiSCR75 at Week 16. H= iSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduct= ion from baseline in the total abscess and inflammatory nodule count, with = no increase from baseline in abscess or draining tunnel count.=C2=A0 Results from BE HEARD I and BE HEARD II showed that a significantly higher = proportion of patients treated with bimekizumab versus placebo achieved a 5= 0 percent or greater improvement in HS signs and symptoms at Week 16, as me= asured by HiSCR50, the primary endpoint in both trials. Bimekizumab treatme= nt also resulted in clinically meaningful improvements in the ranked key se= condary endpoint, HiSCR75 versus placebo at Week 16. =C2=A0Responses were m= aintained to Week 48. The safety profile of bimekizumab was consistent with= safety data seen in previous trials with no new observed safety signals. About BIMZELX^=C2=AE (bimekizumab) BIMZELX^=C2=AE (bimekizumab) is a humanized monoclonal IgG1 antibody design= ed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F= (IL-17F), two key cytokines driving inflammatory processes.^1,4=C2=A0 The = therapeutic indications in the EU are:^1 =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.=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).=C2=A0 =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 = the treatment of adults with active ankylosing spondylitis who have respond= ed inadequately or are intolerant to conventional therapy.=C2=A0 =C2=B7 Hidradenitis suppurativa: Bimekizumab is indicated for the treatment= of active moderate to severe hidradenitis suppurativa (HS; acne inversa) i= n adults with an inadequate response to conventional systemic HS therapy. BIMZELX^=C2=AE =E2=96=BC (bimekizumab) EU/EEA* Important Safety Information= ^1 The most frequently reported adverse reactions with bimekizumab were upper = respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis= , psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis sup= purativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO= , PsA, axSpA and HS, respectively). Common adverse reactions (=E2=89=A51/10= 0 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes= simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculit= is, vulvovaginal mycotic infection (including vulvovaginal candidiasis), he= adache, rash, dermatitis and eczema, acne, injection site reactions, fatigu= e. Elderly may be more likely to experience certain adverse reactions such = as oral candidiasis, dermatitis and eczema when using bimekizumab. Bimekizumab is contraindicated in patients with hypersensitivity to the act= ive substance or to any of the excipients and in patients with clinically i= mportant 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: April 2024. https://u7061146.ct.sendgrid.ne= t/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba= -2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZtxZSt9alTJN= B3GCtxa-2FoK-2BOTzRR_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z= 2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6= FohpNoV33EIfh7JrrTBvNRLtG5Nps6v-2BaYlDVNGRj5fP6ozk7SdypmAJOSEPkCILZg9ITTRY9= 1v0NDW49ovP012aIx4QV7buE3kJ-2B4tWTu5LIAsN4tuhv1-2BDpNEy1WtFtZC6c-2BYOctVKot= nvUxCIatg2uf-2FRj5s-2FeeLXxCKJfDZedqCAHNqJJAHppgtGYN-2F-2BzzNCoN1ONmAObIOT7= kj5hdjs5pJNPoF-2FNpJxWIi4HX783fVEMAVI-3D information_en.pdf=C2=A0 (https://= u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3= Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6= JMudpi5XOwHZtyAHZJBd6YRdp1RSNV5wqOW-2B2nuMhJvPUY2IJDXRoqHUQ-3D-3Dv6ar_2dCLU= NbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6= ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33EIfh7JrrTBvNRLtG5= Nps6v-2BaYlDVNGRj5fP6ozk7SdypmAJOSEPkCILZg9ITTRY91v0NDW49ovP012aIx4QV7THONN= FktRQw45OfEG1DK4PFmeS3byzaioe9QG-2FhQScVa5fnm1eM1iv4v9VuGJvX-2Fp-2Bl02NPKWm= Odc2J-2F8Hz2uJRaJZOhMNVnZ2Lbs5Hg91TpyKi-2B79EpQXMB-2F0ooag-2Br4KiKRLBA6bdU0= IqkoeSBUw-3D *EU/EEA means European Union/European Economic Area =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. 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 9,000 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. 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BIMZELX^=C2=AE (bimekizumab) EU SmPC. https://u7061146.ct.sendgrid.net/l= s/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2B= L1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZtyAHZJBd6YRdp1= RSNV5wqOWwE2cRsny7Ehx4x7oG7pgXg-3D-3D_xDv_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFG= M-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8= cV3s33SbkEZvEGLNn-2B6FohpNoV33EIfh7JrrTBvNRLtG5Nps6v-2BaYlDVNGRj5fP6ozk7Sdy= pmAJOSEPkCILZg9ITTRY91v0NDW49ovP012aIx4QV7VvvD7LiLIyCGQfqPGEx0frggAwjsau353= 9ru62-2FUxKmW13bMtB1mQks1UDugWCj9MxIeMjmVB4vHJF-2Bqg4HNwMg7dvifg8KKks5MXnWD= hFO67hq73CU6TecI27LEKk-2FpIEYJlyhhxurvsoMuINCvpc-3D April 2024. 2. Jemec GB. Clinical practice: hidradenitis suppurativa. N Engl J Med. 201= 2;366(2):158-64. 3. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev= Dis Primers. 2020;6(1):18. 4. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi= mekizumab, a humanized monoclonal antibody and selective dual inhibitor of = IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991= =E2=80=931001. 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UCB (EBR:UCB) UCB Media Room: European Commission approval for BIMZELX®▼(bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe HS

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