UCB (EBR:UCB) UCB Media Room: Bimekizumab 48-week Phase 3 analyses in moderate to severe hidradenitis suppurativa showed sustained improvements in skin pain and draining tunnel count

Transparency directive : regulatory news

08/03/2024 18:00

https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC= rjYrJUHPDVbu1NKaBE-3DAB0b_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33fapog-2FIENHAbDLGXQN0JqmvqjLti0oFAjFBJ30x9OZKGRLeGEccsItg52zc= Wuw4k2mudYEAZknZ-2Bs38AqbArQu4bAEhEp1LTkIA-2BOPCkSOWMn8mt7HI5p3mAkDB2lBCq6l= 5OzgmbowVG9M9lYPy6AmefIyhmaWxLJ-2F5rgZRDbdmH49TUgxtboHvh-2F6YME5tULPMUQcmFx= n-2B0n9dxyXwUZ5r8Mk7Hg28NzkM75ayK2ek-3D ** Bimekizumab 48-week Phase 3 analyses in moderate to severe hidradenitis = suppurativa showed sustained improvements in skin pain and draining tunnel = count ------------------------------------------------------------ =C2=B7 Patients treated with bimekizumab demonstrated clinically meaningful= improvements in skin pain up to 48 weeks, across various assessed outcomes =C2=B7 At Week 16, patients treated with bimekizumab demonstrated greater d= raining tunnel reductions versus placebo that were sustained or improved to= Week 48 =C2=B7 Disease-associated pain and draining tunnels can highly impact the q= uality of life of people living with moderate to severe hidradenitis suppur= ativa Brussels (Belgium), 8 March, 2024 =E2=80=93 18:00 (CET) =E2=80=93 UCB, a gl= obal biopharmaceutical company, today announced 48-week post-hoc analyses o= f pooled Phase 3 data from the BE HEARD I and BE HEARD II studies examining= the impact of bimekizumab on skin pain and draining tunnels in adults with= moderate to severe hidradenitis suppurativa (HS). These results are shared= at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Di= ego, California, U.S., March 8=E2=80=9312. Analyses showed that bimekizumab-treated patients reported clinically meani= ngful improvements in skin pain up to 48 weeks across various assessed outc= omes, including the HS Symptom Questionnaire (HSSQ) skin pain item, the Pat= ient Global Impression of Severity of Skin Pain (PGI-S-SP) and the Change i= n Severity of Skin Pain (PGI-C-SP).[1] Additionally, patients demonstrated = greater reductions in draining tunnel count compared to those on placebo at= Week 16. Responses were either sustained or improved to Week 48.[2]^ =E2=80=9CThe majority of patients with hidradenitis suppurativa experience = disease-associated pain that can impact their quality-of-life. Data from th= e Phase 3 studies show that after 48 weeks of bimekizumab treatment approxi= mately six out of ten patients rated their skin pain =E2=80=98much better= =E2=80=99,=E2=80=9D said Dr. Hadar Lev-Tov, MD, Associate Professor, Dr. Ph= illip Frost Department of Dermatology and Cutaneous Surgery, University of = Miami, Miller School of Medicine, Florida, U.S.=C2=A0=E2=80=9CThese long-te= rm results are encouraging, especially given that pain is a common complain= t in people with HS that dermatologists struggle with daily.=E2=80=9D =E2=80=9CThe bimekizumab 48-week long-term data in moderate to severe hidra= denitis suppurativa showed sustained improvements in skin pain and draining= tunnel count. These positive results underscore our commitment to developi= ng solutions that make a meaningful and lasting difference to peoples=E2=80= =99 lives,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immun= ology Solutions and Head of U.S., UCB. =E2=80=9CWe are actively pursuing re= gulatory applications across the globe to bring bimekizumab to the hidraden= itis suppurativa community.=E2=80=9D Bimekizumab is not approved for the treatment of moderate to severe HS by a= ny regulatory authority worldwide. The efficacy and safety profile of bimek= izumab in the treatment of moderate to severe HS have not been established = and this is an investigational indication only. At baseline, adult patients (N=3D1,014) were randomized 2:2:2:1 (initial/ma= intenance) to receive, either bimekizumab 320 mg every two weeks Q2W/Q2W (n= =3D288), bimekizumab Q2W/Q4W (n=3D292), bimekizumab Q4W/Q4W (n=3D288) or pl= acebo/bimekizumab Q2W (n=3D146).^1^,^2 Across treatment groups, the mean ba= seline HSSQ skin pain score was 5.8 (on a scale of 0-10, with higher score = indicating more pain).^1 At baseline, 72.8 percent of patients had draining= tunnels with the count comparable across regimens (mean range 3.3=E2=80=93= 3.8).^2 Highlights of the bimekizumab data in moderate to severe HS presented at AA= D 2024: Impact on pain: =C2=B7 At Week 48, HSSQ skin pain response was achieved by 64.6=E2=80=9375.= 7 percent of patients.^1^* =C2=B7 At Week 48, HSSQ skin pain score of 0 was achieved by 12.7=E2=80=931= 9.8 percent of patients.^1^* =C2=B7 From Weeks 0=E2=80=9348, HSSQ skin pain scores reduced by 36.9=E2=80= =9343.7 percent across treatment groups.^1^=C2=B1 =C2=B7 At Week 48, 55.9=E2=80=9363.7 percent of patients rated their skin p= ain =E2=80=9Cmuch better=E2=80=9D using the PGI-C-SP.^1^* =C2=B7 At Week 48, 3.9=E2=80=937.8 percent rated PGI-S-SP =E2=80=9Csevere= =E2=80=9D vs. 28.5-33.3 percent at baseline and 45.6=E2=80=9347.4 rated PGI= -S-SP =E2=80=9Cmild=E2=80=9D vs. 15.1=E2=80=9316.7 percent at baseline.^1^* Impact on draining tunnel count: =C2=B7 At Week 16, the draining tunnel percent change from baseline (CfB) w= as higher with bimekizumab vs. placebo (-43.9 to -45.7 vs. -21.5 percent). = Bimekizumab-treated patients also saw greater absolute changes in draining = tunnel count vs. placebo.^2^=C2=B1 =C2=B7 The percentage and absolute CfB increased through Week 48 across all= bimekizumab groups.^2^=C2=B1 =C2=B7 At Week 16, greater proportions of bimekizumab-treated patients saw = draining tunnel reductions of three or more vs. those on placebo (58.0=E2= =80=9370.6 vs. 35.0 percent), with responses sustained or improved to Week = 48 across regimens (79.4=E2=80=9388.7 percent).^2^* ^*Observed case. =C2=B1Multiple imputation Notes to editors: About hidradenitis suppurativa (HS) Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilit= ating inflammatory skin disease.[3]^,[4]^ The main symptoms are nodules, ab= scesses, and pus-discharging draining tunnels (or sinus tracts leading out = of the skin) which typically occur in the armpits, groin, and buttocks.^3^,= ^4 People with HS experience flare-ups of the disease as well as severe pai= n, which can have a major impact on quality of life.^3^,^4 HS develops in e= arly adulthood and affects approximately one percent of the population in m= ost studied countries.^3^,^4 About BE HEARD I and BE HEARD II The efficacy and safety profile of bimekizumab were evaluated in adult pati= ents with moderate to severe hidradenitis suppurativa (HS) in two multicent= re, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD = I and BE HEARD II).[5]^,[6] The two studies had a combined enrolment of 1,0= 14 participants.^5^,^6 The primary endpoint in both trials was HiSCR50 at W= eek 16.^5^,^6 A key secondary endpoint was HiSCR75 at Week 16.^5^,^6 HiSCR5= 0 and HiSCR75 are defined as at least either a 50 or 75 percent reduction f= rom baseline in the total abscess and inflammatory nodule count, with no in= crease from baseline in abscess or draining tunnel count.^5^,^6 About BIMZELX^=C2=AE BIMZELX^=C2=AE is a humanized monoclonal IgG1 antibody that is designed to = selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-1= 7F), two key cytokines driving inflammatory processes.[7] In the U.S., bimekizumab-bkzx is approved for the treatment of moderate to = severe plaque psoriasis in adults who are candidates for systemic therapy o= r phototherapy.[8] Bimekizumab is not approved in the U.S. for the treatment of moderate to se= vere hidradenitis suppurativa (HS). The efficacy and safety profile of bime= kizumab in HS have not been established, and it is not approved for use in = HS by any regulatory authority worldwide. The approved indications for bimekizumab in the European Union are:[9] =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. 9 =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). 9 =C2=B7 Axial Spondyloarthritis: Bimekizumab is indicated for the treatment = of adults with active non=E2=80=91radiographic axial spondyloarthritis with= objective signs of inflammation as indicated by elevated C=E2=80=91reactiv= e protein (CRP), and/or magnetic resonance imaging (MRI), who have responde= d inadequately or are intolerant to non-steroidal anti-inflammatory drugs (= NSAIDs), and for the treatment of adults with active ankylosing spondylitis= who have responded inadequately or are intolerant to conventional therapy.= ^9 The label information may differ in other countries where approved. Please = check local prescribing information. In the U.S., bimekizumab-bkzx is not approved for the treatment of psoriati= c arthritis or axial spondyloarthritis and these are investigational indica= tions only. BIMZELX U.S. IMPORTANT SAFETY INFORMATION^8 Please see Important Safety Information below and full U.S. prescribing inf= ormation at www.UCB- (https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.= b00YhNV2Nr0-2BaZn7eVNAdfGZi1a7X9NeZMGrLhKNUu7h9rj85yIm-2BJQyDHDxAfTjDGCgwTQ= -2Fy3VuTuEtRgHDMw-3D-3Dwmtb_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl= -2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEG= LNn-2B6FohpNoV33fapog-2FIENHAbDLGXQN0JqmvqjLti0oFAjFBJ30x9OZKGRLeGEccsItg52= zcWuw4k2mudYEAZknZ-2Bs38AqbArQpN4luGf5lLhFDs2rjCNJAjq2kq8pLxjBrjUMaCcc1m6a3= OeGfLrFlGRWNYkCF-2Fs-2BT0CcMbKQXSkBTjl0XzXYWEHTdT-2BWSrPmGi7f-2B9AQ2G3aLQbE= kO95qIhPcusmsOnlC-2FYuVNqFmcMeC7aUF-2FDQ2s-3D USA.com/Innovation/Products/B= IMZELX (https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.b00YhNV2Nr0-2B= aZn7eVNAdfGZi1a7X9NeZMGrLhKNUu7h9rj85yIm-2BJQyDHDxAfTjDGCgwTQ-2Fy3VuTuEtRgH= DMw-3D-3DP8bH_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BI= fez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV= 33fapog-2FIENHAbDLGXQN0JqmvqjLti0oFAjFBJ30x9OZKGRLeGEccsItg52zcWuw4k2mudYEA= ZknZ-2Bs38AqbArQq1O2Epi2iHeaZAyTIHVIGDLsu2Ez-2F8G7sFOc9u4-2Fv3K1hlzs3wg3FQ5= TY-2Fl-2FaF6N10lFzOU1TwBrwe21E9uZpEGtBqnC9zSZboms5Zbuc9Ra-2FyMrrIZ9pNhtZ6Xv= AXEufUfB6ANXxAMW9l-2By2x2048-3D .=C2=A0 Suicidal Ideation and Behavior BIMZELX^=C2=AE (bimekizumab-bkzx) may increase the risk of suicidal ideatio= n and behavior (SI/B). A causal association between treatment with BIMZELX = and increased risk of SI/B has not been established. Prescribers should wei= gh the potential risks and benefits before using BIMZELX in patients with a= history of severe depression or SI/B. Advise monitoring for the emergence = or worsening of depression, suicidal ideation, or other mood changes. If su= ch changes occur, advise to promptly seek medical attention, refer to a men= tal health professional as appropriate, and re- evaluate the risks and bene= fits of continuing treatment. Infections BIMZELX may increase the risk of infections. Do not initiate treatment with= BIMZELX in patients with any clinically important active infection until t= he infection resolves or is adequately treated. In patients with a chronic = infection or a history of recurrent infection, consider the risks and benef= its prior to prescribing BIMZELX. Instruct patients to seek medical advice = if signs or symptoms suggestive of clinically important infection occur. If= a patient develops such an infection or is not responding to standard ther= apy, monitor the patient closely and do not administer BIMZELX until the in= fection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treat= ment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infe= ction. Initiate treatment of latent TB prior to administering BIMZELX. Cons= ider anti-TB therapy prior to initiation of BIMZELX in patients with a past= history of latent or active TB in whom an adequate course of treatment can= not be confirmed. Closely monitor patients for signs and symptoms of active= TB during and after treatment. Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX.= Test liver enzymes, alkaline phosphatase and bilirubin at baseline, period= ically during treatment with BIMZELX and according to routine patient manag= ement. If treatment-related increases in liver enzymes occur and drug-induc= ed liver injury is suspected, interrupt BIMZELX until a diagnosis of liver = injury is excluded. Permanently discontinue use of BIMZELX in patients with= causally associated combined elevations of transaminases and bilirubin. Av= oid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients tr= eated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in pat= ients with active IBD. During BIMZELX treatment, monitor patients for signs= and symptoms of IBD and discontinue treatment if new onset or worsening of= signs and symptoms occurs. Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vacc= inations according to current immunization guidelines. Avoid the use of liv= e vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common adverse reactions (=E2=89=A5 1%) are upper respiratory infectio= ns, oral candidiasis, headache, injection site reactions, tinea infections,= gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Cand= ida infections, and fatigue. ** BIMZELX^=C2=AE=E2=96=BC(bimekizumab) EU/EEA* Important Safety Informatio= n^9 ------------------------------------------------------------ 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 initiating treatment with bimekizumab, patients should be evaluate= d for tuberculosis (TB) infection. Bimekizumab should not be given in patie= nts 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. https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= C2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQ= d4uSQwA6JMudpi5XOwHZtyAHZJBd6YRdp1RSNV5wqOW9bXtWvsAqZERe5h1aJ-2FJNQ-3D-3D2D= Ib_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz= 3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33fapog-2FI= ENHAbDLGXQN0JqmvqjLti0oFAjFBJ30x9OZKGRLeGEccsItg52zcWuw4k2mudYEAZknZ-2Bs38A= qbArQnanWOlk-2FyI-2BK7L8-2FMHlrEaLrpkxBwEpQKjfrRyFQFlEDagqTqMEPiSkjCMYThbiK= wHjKjd4UTnj5Y9H2VTTGcROWg6OX5hZa3qXvetKWWcBhc7DS7jOhpLwzknne0-2Fhya-2BL9H8k= ZLODYIlTGiVNC90-3D *EU/EEA means European Union/European Economic Area Last accessed: March 20= 24. =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: Investor Relations Antje Witte T +32.2.559.94.14 email antje.witte@ucb.com (mailto:antje.witte@ucb.com) Corporate Communications Laurent Schots T +32.2.559.92.64 email laurent.schots@ucb.com (mailto:laurent.schots@ucb.com) Brand Communications Eimear O=E2=80=99Brien T +32.2.559.92.71 email eimear.obrien@ucb.com (mailto:eimear.obrien@ucb.com) About UCB 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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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. 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. References 1. Orenstein L, Shi V, Lev-Tov H, et al. Bimekizumab impact on pain in mode= rate to severe hidradenitis suppurativa: Week 48 results from BE HEARD I & = II. Abstract at the 2024 American Academy of Dermatology Annual Meeting, Sa= n Diego, CA, U.S., March 8=E2=80=9312, 2024. 1. Zouboulis CC, Hsiao J, Reguiai Z, et al. Bimekizumab impact on draining = tunnels in patients with moderate to severe hidradenitis suppurativa: Poole= d 48-week data from BE HEARD I & II. Abstract at the 2024 American Academy = of Dermatology Annual Meeting, San Diego, CA, U.S., March 8=E2=80=9312, 202= 4. 1. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 20= 12;366(2):158-64. 1. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev= Dis Primers. 2020;6(1):18. 1. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek= izumab in Study Participants With Moderate to Severe Hidradenitis Suppurati= va (BE HEARD I). https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2= BaxUzlo7XKIuSly0rC8x9ma-2BvZ4KO7y-2BRulIZR4rC-2FQTQfUn-2BC-2BV0fzas5zw1jPBV= 0YsYTO2ymy9oPajPXO95zdIeYY1HLE60W7dtwDzuXotJdrzeHcZA3wiDriBP7fuO_2dCLUNbuBj= hX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4= gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33fapog-2FIENHAbDLGXQN0J= qmvqjLti0oFAjFBJ30x9OZKGRLeGEccsItg52zcWuw4k2mudYEAZknZ-2Bs38AqbArQqTs7vTRN= xQjkbbwvm6kQ4n6aPGC845znqwNs9utvItx6CtIzSmC-2BbmfEyYnxbjtsoxucKWxtB2tYD1z1y= AKqxpozGSlli78nrYp0jwZ0a-2BfdKDBPFGU0taZq3T9t3zXBiGptfEDlgTfcb8i7UeJZNI-3D = Accessed date: March 2024. 1. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek= izumab in Study Participants With Moderate to Severe Hidradenitis Suppurati= va (BE HEARD II). https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-= 2BaxUzlo7XKIuSly0rC01soZwuNnrsR8mFaEy8YaOQaERx5QgNLsjH5WYhRNm8yikbRQvzAzPoE= NYToh6Xa6YDzQlyu0BJ1SHmMRLTlys-3DAHpv_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2B= PPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s= 33SbkEZvEGLNn-2B6FohpNoV33fapog-2FIENHAbDLGXQN0JqmvqjLti0oFAjFBJ30x9OZKGRLe= GEccsItg52zcWuw4k2mudYEAZknZ-2Bs38AqbArQudQn32m55gwm5CzXv3nG6qhhWE3-2Bp5nkF= lgtFshPZPRU49zccpXYZbHFshL5M2uV-2FogW52hXg3s01B2Q56ZowYjAYxtfkJ3-2B04eCsv5x= c1yPX0vqXWx8wSBvH7jQwucH-2FgzGR5Wz5nx2XcsIuLoQSE-3D =C2=A0Accessed date: Ma= rch 2024. 1. 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):991-1= 001. 1. BIMZELX^=C2=AE (bimekizumab-bkzx) U.S. PI. https://u7061146.ct.sendgrid.= net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC8ikjD3-2B-2FLuLRRIcxGl3OVRMl= d-2BlylPyaHB5-2F88LuoKZ9UGq4aHxAiJW023RnaEtLA-3D-3DrwKw_2dCLUNbuBjhX746-2Fv= M63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MT= dQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33fapog-2FIENHAbDLGXQN0JqmvqjLti0= oFAjFBJ30x9OZKGRLeGEccsItg52zcWuw4k2mudYEAZknZ-2Bs38AqbArQiHGNVevTkoufmCPD7= blZyO8KZIDbEHqhhHJFLEx8QmIFtr-2FVZU0oluoGW7alCE7LxfU9CSNSNuanwI8uMTdssSNLaS= s-2FHxkzWohIQDo78CFb6oKtLoeI8O46DG8NX6rEI4QU2d3adRntP7q-2BVpH46U-3D Accesse= d: March 2024. 1. BIMZELX^=C2=AE (bimekizumab) EU SmPC. Available at: https://u7061146.ct.= sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj= 7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZ= tyAHZJBd6YRdp1RSNV5wqOWwE2cRsny7Ehx4x7oG7pgXg-3D-3D4ipj_2dCLUNbuBjhX746-2Fv= M63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MT= dQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33fapog-2FIENHAbDLGXQN0JqmvqjLti0= oFAjFBJ30x9OZKGRLeGEccsItg52zcWuw4k2mudYEAZknZ-2Bs38AqbArQkqkoG8dd8LHcjF8Cj= zpWI-2BUqUnwu3xFiwKXg9fm6PDRnbhzyDDOzF-2FrNvZfIZ6xZ5Ppe9T6g1-2B5JWoVQ2NWhU9= pB1MxTwJ8YLaS6-2B7ZMIJGQwAGKGH3NCzh4rtpKPkPr4VhHU8ed5bMw4r0GXL-2Bd3E-3D Acc= essed: March 2024. GenericFile AAD HS Press Release Friday 08032024 1800CET (https://u7061146.ct.sendgrid.= net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyBv9bezcPT-2BuItTLKIHepZ1ZJy= Ssq-2FzjbU8chrb0nkD9aQYH0i6ollCb1XkjIpnJ7-2Fx1dFOmgJT0LdhHM-2Bs9cU-3D49Er_2= dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mpl= cEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33fapog-2FIENHA= bDLGXQN0JqmvqjLti0oFAjFBJ30x9OZKGRLeGEccsItg52zcWuw4k2mudYEAZknZ-2Bs38AqbAr= Qm4PePDKfSYKRXv88FjNoNk6liv3exv9yA3U1rlnt3LszXBacbE9LlSRYxzAKhSgpoCn-2BMAxx= KJlwrmPfFXpCoKNsW1FstSLKjK56lXjJelkix4mQMHVMvp1ln6lKxWTb8C1j5TcLkkDxo6pvRZT= sn8-3D ______________________ 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-2BrYPIUNPgUf5Yz0MZE3fNebHZBBES49= X4d2ZgpoYkYYJhC7gtydPW-2Bera5Vf-2FqEfvrOJJ3a4ZDL1qnIAFmrwcEtSy6ALkWyCLYB6lp= FRJhp11RLKZI-3DTbBW_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2= nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6F= ohpNoV33fapog-2FIENHAbDLGXQN0JqmvqjLti0oFAjFBJ30x9OZKGRLeGEccsItg52zcWuw4k2= mudYEAZknZ-2Bs38AqbArQucq3yDfrcmJwXIDnzHKm12vPo56GrSl5I2m1WhIeWx0GLyOE0ppTy= 2oa4k1WNU7gnMGt8T22WnoYwUIlI5dhyt9j8p9i0WfnGTqFw9njyYFaA-2BDs5R2o1LaGMUqjXW= N190PzXWQtyylq7Gc8Qw4P-2FE-3D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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UCB (EBR:UCB) UCB Media Room: Bimekizumab 48-week Phase 3 analyses in moderate to severe hidradenitis suppurativa showed sustained improvements in skin pain and draining tunnel count

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