UCB (EBR:UCB) UCB Media Room: Positive CHMP opinion for BIMZELX®▼(bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa

Transparency directive : regulatory news

22/03/2024 07:00

https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC= rjYrJUHPDVbu1NKaBE-3D47g-_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33bmOTT4LtKtILLAgjlSzidGq5pfvIrElAmFCJi75egfAudmPkzxR-2FgEZTHLQ= 1mQAC7CXybuA7MypxYhMKhmSc6DzKzOwYaY032yDZF87UaTJ0-2BJ7xyyu4sD6RNySuh6ZMDS-2= FVFhRVDAl6IRigz2SuX-2BUjylcWiwBEMjIcfT61K2RHoR0Ne1Ml8fAEvwz4aCINlw7jPJ26kom= RRyXqssadvI81dRHb6iKYzrVATg0Wtnw-3D ** UCB receives positive CHMP opinion for BIMZELX^=C2=AE=E2=96=BC(bimekizum= ab) for the treatment of adults with moderate to severe hidradenitis suppur= ativa ------------------------------------------------------------ =C2=B7 Positive CHMP opinion is supported by data from the two Phase 3 stud= ies, BE HEARD I and BE HEARD II, where bimekizumab showed clinically meanin= gful improvements vs. placebo at Week 16 which were sustained to Week 48 =C2=B7 If approved by the European Commission, bimekizumab would be the fir= st biologic for moderate to severe hidradenitis suppurativa to target IL-17= F in addition to IL-17A=C2=A0 =C2=B7 Hidradenitis suppurativa is one of the most burdensome, chronic, inf= lammatory skin diseases that has a profound impact on patients=E2=80=99 hea= lth-related quality of life, and for which there are currently few approved= treatment options =C2=A0 Brussels (Belgium), 22 March 2024 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a gl= obal biopharmaceutical company, today=C2=A0announced that the Committee for= Medicinal Products for Human Use (CHMP) of the European Medicines Agency (= EMA) has issued a positive opinion recommending granting marketing authoriz= ation for BIMZELX^=C2=AE (bimekizumab) in the European Union (EU)/European = Economic Area (EEA) for the treatment of active moderate to severe hidraden= itis suppurativa (HS; acne inversa) in adults with an inadequate response t= o conventional systemic HS therapy. If approved by the European Commission = (EC), bimekizumab will be the first IL-17A and IL-17F inhibitor approved in= the EU for the treatment of adults with moderate to severe HS. =E2=80=9CThe positive opinion from the CHMP represents a significant milest= one toward bringing bimekizumab to people living with moderate to severe hi= dradenitis suppurativa, a chronic, painful inflammatory skin disease with l= imited treatment options,=E2=80=9D said Emmanuel Caeymaex, Executive Vice P= resident, Immunology Solutions, and Head of U.S., UCB. =C2=A0=E2=80=9CIf ap= proved by the European Commission, this would represent the fourth marketin= g authorization for bimekizumab in three years, adding to the existing indi= cations in moderate to severe plaque psoriasis, active psoriatic arthritis = and active axial spondyloarthritis.=E2=80=9D=C2=A0 =C2=A0 HS is a chronic inflammatory skin disease that manifests as nodules, absces= ses and pus-discharging fistulas, i.e., channels leading out of the skin, t= ypically in the armpits, groin, and buttocks.^1 HS affects approximately on= e percent of the population in most studied countries with those affected e= xperiencing flare-ups of the disease as well as severe pain.^1,2,3=C2=A0 Pe= ople living with HS also experience social stigma, social isolation and low= self-esteem, all of which have a major impact on their quality of life.^2,= 3=C2=A0 The CHMP positive opinion for bimekizumab is based on findings from the Pha= se 3 BE HEARD I and BE HEARD II studies which evaluated the efficacy and sa= fety of bimekizumab in the treatment of adults with moderate to severe HS.^= 4,5=C2=A0 Data showed that bimekizumab treatment resulted in statistically = significant and clinically meaningful improvements over placebo in the sign= s and symptoms of HS, as measured by HiSCR50 at Week 16, the primary endpoi= nt, with responses sustained to Week 48.^4,5 Bimekizumab treatment also res= ulted in improvements over placebo in the high threshold endpoint, HiSCR75 = at Week 16, a key ranked secondary endpoint, with responses sustained to We= ek 48.^4,5 In both studies the safety profile of bimekizumab was consistent= with data seen in previous studies with no new observed safety signals.^4,= 5=C2=A0 The CHMP positive opinion on bimekizumab in moderate to severe HS will be r= eferred to the EC for its final decision. The marketing authorization would= be applicable to all EU member states as well as countries of the EEA. Notes to editors: About BE HEARD I and BE HEARD II BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled= , parallel group, multicenter, Phase 3 studies designed to evaluate the eff= icacy and safety of bimekizumab in adults with moderate to severe hidradeni= tis suppurativa (HS).^4,5 The two studies had a combined enrolment of 1,014= participants with a diagnosis of moderate to severe HS. The primary endpoi= nt in both studies was HiSCR50 at Week 16.^4,5 A key ranked secondary endpo= int was HiSCR75 at Week 16.^4,5 HiSCR50 and HiSCR75 are defined as at least= either a 50 or 75 percent reduction from baseline in the total abscess and= inflammatory nodule count, with no increase from baseline in abscess or dr= aining tunnel count.^4,5 About BIMZELX^=C2=AE (bimekizumab) 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.^6 The therapeutic indic= ations in the European Union are:^7 =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.^7=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).^7=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.^7=C2=A0 BIMZELX^=C2=AE (bimekizumab) EU/EEA* Important Safety Information^7 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 and fatigue. Elderly individual= s may be more likely to experience certain adverse reactions such as oral c= andidiasis, 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). 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 (https://u7061146.ct.= sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj= 7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZ= tyAHZJBd6YRdp1RSNV5wqOW-2B2nuMhJvPUY2IJDXRoqHUQ-3D-3DiDTD_2dCLUNbuBjhX746-2= FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3= MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33bmOTT4LtKtILLAgjlSzidGq5pfvIr= ElAmFCJi75egfAudmPkzxR-2FgEZTHLQ1mQAC7CXybuA7MypxYhMKhmSc6LfKxuFU3OmB8cSoFf= rdyKTMHq2R-2BzjiFYpl8ua6zQQnEQaoOTM1heEy-2Bq57MwGJDloyb2G32aaPVQW59IiPmUhAL= T6hH4mVsJbrqGLt2xIXRb-2BDtzIjMRMo0BRxdYQlkWegCpzXLz45JZ8oyy6NYZ0-3D in rela= tion to other side effects, full safety and prescribing information.^7=C2= =A0 European SmPC date of revision: November 2023.=C2=A0 Last accessed: March 2024. *EU/EEA means European Union/European Economic Area =E2=96=BCThis medicinal product is subject to additional monitoring. This w= ill allow quick identification of new safety information. Healthcare profes= sionals 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. Forward looking statements=C2=A0 This press release may contain forward-looking statements including, withou= t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, = =E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends= =E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim= ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont= inue=E2=80=9D and similar expressions. These forward-looking statements are= based on current plans, estimates and beliefs of management. All statement= s, other than statements of historical facts, are statements that could be = deemed forward-looking statements, including estimates of revenues, operati= ng margins, capital expenditures, cash, other financial information, expect= ed legal, arbitration, political, regulatory or clinical results or practic= es and other such estimates and results. By their nature, such forward-look= ing statements are not guarantees of future performance and are subject to = known and unknown risks, uncertainties and assumptions which might cause th= e actual results, financial condition, performance or achievements of UCB, = or industry results, to differ materially from those that may be expressed = or implied by such forward-looking statements contained in this press relea= se. Important factors that could result in such differences include: change= s in general economic, business and competitive conditions, the inability t= o obtain necessary regulatory approvals or to obtain them on acceptable ter= ms or within expected timing, costs associated with research and developmen= t, changes in the prospects for products in the pipeline or under developme= nt by UCB, effects of future judicial decisions or governmental investigati= ons, safety, quality, data integrity or manufacturing issues; potential or = actual data security and data privacy breaches, or disruptions of our infor= mation technology systems, product liability claims, challenges to patent p= rotection for products or product candidates, competition from other produc= ts including biosimilars, changes in laws or regulations, exchange rate flu= ctuations, changes or uncertainties in tax laws or the administration of su= ch laws, and hiring and retention of its employees. There is no guarantee t= hat new product candidates will be discovered or identified in the pipeline= , will progress to product approval or that new indications for existing pr= oducts will be developed and approved. Movement from concept to commercial = product is uncertain; preclinical results do not guarantee safety and effic= acy of product candidates in humans. So far, the complexity of the human bo= dy cannot be reproduced in computer models, cell culture systems or animal = models. The length of the timing to complete clinical trials and to get reg= ulatory approval for product marketing has varied in the past and UCB expec= ts similar unpredictability going forward. Products or potential products, = which are the subject of partnerships, joint ventures or licensing collabor= ations may be subject to differences disputes between the partners or may p= rove to be not as safe, effective or commercially successful as UCB may hav= e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui= re other products or companies and to integrate the operations of such acqu= ired companies may not be as successful as UCB may have believed at the mom= ent of acquisition. Also, UCB or others could discover safety, side effects= or manufacturing problems with its products and/or devices after they are = marketed. The discovery of significant problems with a product similar to o= ne of UCB=E2=80=99s products that implicate an entire class of products may= have a material adverse effect on sales of the entire class of affected pr= oducts. Moreover, sales may be impacted by international and domestic trend= s toward managed care and health care cost containment, including pricing p= ressure, political and public scrutiny, customer and prescriber patterns or= practices, and the reimbursement policies imposed by third-party payers as= well as legislation affecting biopharmaceutical pricing and reimbursement = activities and outcomes. Finally, a breakdown, cyberattack or information s= ecurity breach could compromise the confidentiality, integrity and availabi= lity of UCB=E2=80=99s data and systems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release. UCB expressly disclaims any duty t= o update any information contained in this press release, either to confirm= the actual results or to report or reflect any change in its forward-looki= ng statements with regard thereto or any change in events, conditions or ci= rcumstances on which any such statement is based, unless such statement is = required pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction.=C2=A0 References 1. =C2=A0 Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. = Nat Rev Dis Primers. 2020;6(1):18. 2. =C2=A0 Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived = Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosm= et Investig Dermatol. 2019;12(1):785=E2=80=9390. 3. =C2=A0 Kokolakis G, Wolk K, Schneider-Barrus S, et al. Delayed Diagnosis= of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare Syst= em. Dermatology. 2020;236(5):421=E2=80=9330. 4. =C2=A0 Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients= with moderate-to-severe hidradenitis suppurativa: 48-week =C2=A0 efficacy = and safety from BE HEARD I & II, two phase 3, randomized, double-blind, pla= cebo controlled, multicenter studies. Late-Breaking Platform Presentation a= t the American Academy of Dermatology Congress 2023. 5. =C2=A0 Zouboulis C. 2023 EADV. Session S042-45981. 6. =C2=A0 Glatt S, Helmer E, Haier B, et al. First-in-human randomized stud= y of bimekizumab, a humanized monoclonal antibody and selective dual inhibi= tor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5= ):991=E2=80=931001. 7. =C2=A0 BIMZELX^=C2=AE (bimekizumab) EU SmPC. https://u7061146.ct.sendgri= d.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj= -2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZtyAHZJB= d6YRdp1RSNV5wqOWwE2cRsny7Ehx4x7oG7pgXg-3D-3DW27Q_2dCLUNbuBjhX746-2FvM63L9Hy= n3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93= DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33bmOTT4LtKtILLAgjlSzidGq5pfvIrElAmFCJi7= 5egfAudmPkzxR-2FgEZTHLQ1mQAC7CXybuA7MypxYhMKhmSc6DAOQSppbaseUa94Z-2FfDjiAG0= GpD6Zkq60hZ0uqIzbOWDpt6J93-2B7bsilu3DaQe-2BCW0s1cW5w2roCXFKkVhk-2BoDGgJzAVY= 3Yx0djVY544pIBrS8BOu28uxo9O-2BJ4frXZ-2Ffo2gx94SwGtqzjFgFGG65o-3D Accessed M= arch 2024. GenericFile UCB PR BKZ CHMP HS March 22 2024 ENG (https://u7061146.ct.sendgrid.net/ls/c= lick?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyBv9bezcPT-2BuItTLKIHepa9dM6LtSZwZtI= PkR6SL5H12zt-2FRTowIH48R0NyyYWCQ9o3L-2BTAo7NTg82EY-2BwZMDQ-3DcVEl_2dCLUNbuB= jhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ= 4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33bmOTT4LtKtILLAgjlSzid= Gq5pfvIrElAmFCJi75egfAudmPkzxR-2FgEZTHLQ1mQAC7CXybuA7MypxYhMKhmSc6IsOT-2BaF= mLg7SkDUcmb5VxoDtrwKmWDVRSfIcxDkWC56gGuQ3-2FAMyMX0tHFZUjmcBE8rkwDXq-2Bih3RM= XIGyDFgKTvEMTi8Yb2NczxoKvje0GkFTyNNjegh8PV2DCTDu7wMXFgRVo-2BRrBHsom-2Bk5FMz= I-3D ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIu= Sly0rC3nfmD42E6tJ6HwHGmqtXbhtXDlQ2cTEdRpWV-2BrYPIUN4zCUWMF-2FgJTTuKp5k2gmqs= 2hTkzstCtqmKY9-2FNBzsHQz1LGun2oW8zoM-2BTagGFO6pHxkMl-2BezehCNEU-2BOFz-2Bvco= 1FyZTvc9PKTQNQpp89yI-3DAr3a_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl= -2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEG= LNn-2B6FohpNoV33bmOTT4LtKtILLAgjlSzidGq5pfvIrElAmFCJi75egfAudmPkzxR-2FgEZTH= LQ1mQAC7CXybuA7MypxYhMKhmSc6GqIcc9OVJu35AI9xdcmJGIvsQ-2BeTjAUcXjLFNHCwAw8Wf= b-2FScRi-2BfiiEK8PkW-2FREZZC6BiV1pivFVj9iksAzjRkAQ4Sta0Nsbk8WVpn2t-2Fiz2psO= FUHc6R8rJ84Wk3KX40pjCGAQ1o9qEt-2FB2LaWZc-3D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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UCB (EBR:UCB) UCB Media Room: Positive CHMP opinion for BIMZELX®▼(bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa

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