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UCB (EBR:UCB) UCB Media Room: FDA Accepts Supplemental BLA for BIMZELX® (bimekizumab-bkzx) for Moderate to Severe HS and Additional 2mL Device Presentations

Transparency directive : regulatory news

04/04/2024 07:02
https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC= rjYrJUHPDVbu1NKaBE-3DLH3S_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33UB68ygh0ruRywTiDmGOMH1pAk-2FmoymRIIpemO551vPNmKt1rsmbXWZ1nbo6= WZdThfpFvRbPBoFvjqyCSuuY9Cg509JoLOILXEXRayxuD-2Fg94-2FYfI1y9AEEsq-2FpyE2XfZ= qCTiI6C8juyvEMDlBI4kMJJiKBsw6kQLGQYBI4lsH8-2FvspfwTNnlnjqUdxIyluJ4WHoMdJUE7= qnK4SJ2Kw-2B8Tvo9wYlIxfoLxfcpLZ8OwPs-3D ** FDA Accepts Supplemental Biologics License Applications for BIMZELX^=C2= =AE (bimekizumab-bkzx) for Moderate to Severe Hidradenitis Suppurativa and = Additional 2mL Device Presentations ------------------------------------------------------------ =C2=B7 Application in moderate to severe hidradenitis suppurativa based on = results from two Phase 3 studies where bimekizumab-bkzx showed clinically m= eaningful improvements vs. placebo at Week 16 which were sustained to Week = 48 =C2=B7 Application for the additional bimekizumab-bkzx 2mL device presentat= ions aims to provide more options to optimize the individual patient experi= ence=C2=A0 Brussels (Belgium), April 4, 2024 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a gl= obal biopharmaceutical company, today announced that the U.S. Food and Drug= Administration (FDA) has accepted for review the supplemental Biologics Li= cense Application (sBLA) for BIMZELX^=C2=AE (bimekizumab-bkzx), an IL-17A a= nd IL-17F inhibitor, for the treatment of adults with moderate to severe hi= dradenitis suppurativa (HS). In addition, a second sBLA for the bimekizumab= -bkzx 2mL device presentations has also been accepted. =E2=80=9CWe are excited to share the progress on our FDA applications. The = most recent sBLA seeks approval for bimekizumab-bkzx in moderate to severe = hidradenitis suppurativa, and is aligned to our goal of expanding the reach= of bimekizumab to more patients living with IL-17 mediated diseases,=E2=80= =9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions,= and Head of U.S., UCB. =E2=80=9CIn addition, the sBLA for the 2mL device p= resentations aims to offer increased convenience for patients. Today, one d= ose of bimekizumab in moderate to severe plaque psoriasis, is administered = as two 1mL injections. Approval of the 2mL device presentations would mean = that patients would have an alternative one injection regimen option.=E2=80= =9D=C2=A0 These new regulatory milestones represent two of five sBLAs accepted by the= FDA for bimekizumab-bkzx in 2024, following the previously announced appli= cations in psoriatic arthritis (PsA), non-radiographic axial spondyloarthri= tis (nr-axSpA) and ankylosing spondylitis (AS). BIMZELX^=C2=AE was first ap= proved in the U.S. in October 2023 for the treatment of moderate to severe = plaque psoriasis in adults who are candidates for systemic therapy or photo= therapy.^1 Bimekizumab-bkzx is not approved in the U.S. for the treatment o= f moderate to severe HS, PsA, nr-axSpA and AS, or for the 2mL device presen= tation. In the U.S., the efficacy and safety of bimekizumab-bkzx in the tre= atment of moderate to severe HS, PsA, nr-axSpA and AS have not been establi= shed and these are investigational indications only.=C2=A0 The sBLA in moderate to severe HS is supported by data from the Phase 3 BE = HEARD I and BE HEARD II studies where bimekizumab-bkzx demonstrated clinica= lly meaningful improvements in HiSCR50 vs. placebo at Week 16, the primary = endpoint.^2 A greater proportion of patients treated with bimekizumab vs. p= lacebo also achieved HiSCR75 at Week 16, a key secondary endpoint.^2 In add= ition, over 48 weeks, improvements increased for patients in these studies.= ^2 The safety profile of bimekizumab-bkzx was consistent with previous stud= ies with no new safety signals observed.^2 =C2=A0 The sBLA for the additional device presentations seeks approval of bimekizu= mab-bkzx 2mL safety syringe and 2mL autoinjector with the aim of providing = a second option to the currently approved 1mL presentations. Notes to editors: About hidradenitis suppurativa (HS) Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilit= ating inflammatory skin disease that is associated with systemic manifestat= ions.^3,4=C2=A0 The main symptoms are nodules, abscesses, and pus-dischargi= ng tunnels (channels leading out of the skin) which typically occur in the = armpits, groin, and buttocks.^3,4 People with HS experience flare-ups of th= e disease as well as severe pain, which can have a major impact on quality = of life. HS develops in early adulthood and affects approximately one perce= nt of the population in most studied countries.^3,4=C2=A0 About BE HEARD I and BE HEARD II The efficacy and safety of bimekizumab-bkzx were evaluated in adult patient= s with moderate to severe hidradenitis suppurativa (HS) in two multicentre,= randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I a= nd BE HEARD II). The two studies had a combined enrolment of 1,014 particip= ants with a diagnosis of moderate to severe HS.^5,6=C2=A0 The primary endpo= int in both trials was HiSCR50 at Week 16.^5,6 A key secondary endpoint was= HiSCR75 at Week 16. HiSCR50 and HiSCR75 are defined as at least either a 5= 0 or 75 percent reduction from baseline in the total abscess and inflammato= ry nodule count, with no increase from baseline in abscess or draining tunn= el count.^5,6=C2=A0 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.^1 =C2=A0Bimekizumab-bkzx is not approved in the U.S. for th= e treatment of moderate to severe HS, PsA, nr-axSpA and AS, or for the 2mL = device presentation. In the U.S., the efficacy and safety of bimekizumab-bk= zx in the treatment of moderate to severe HS, PsA, r-axSpA and AS have not = been established and these are investigational indications only.=C2=A0 Bimekizumab is not approved in HS by any regulatory authority worldwide.=C2= =A0 The approved indications for bimekizumab=C2=A0=E2=96=BC=C2=A0in the Europea= n Union are^8: =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 o= r are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for= the treatment of adults with active ankylosing spondylitis who have respon= ded inadequately or are intolerant to conventional therapy.=C2=A0 The label information may differ in other countries where approved. Please = check local prescribing information.=C2=A0 BIMZELX^=C2=AE U.S. IMPORTANT SAFETY INFORMATION^1 Please see Important Safety Information below and full U.S. prescribing inf= ormation at www.ucb-usa.com/Innovation/Products/Bimzelx Suicidal Ideation and Behavior BIMZELX^=C2=AE (bimekizumab-bkzx) may increase the risk of suicidal ideatio= n and behavior (SI/B). =C2=A0A causal association between treatment with BI= MZELX and increased risk of SI/B has not been established. =C2=A0Prescriber= s should weigh the potential risks and benefits before using BIMZELX in pat= ients with a history of severe depression or SI/B. Advise monitoring for th= e emergence or worsening of depression, suicidal ideation, or other mood ch= anges. If such changes occur, advise to promptly seek medical attention, re= fer to a mental health professional as appropriate, and re-evaluate the ris= ks and benefits of continuing treatment.=C2=A0 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. =C2=A0In patients with a ch= ronic infection or a history of recurrent infection, consider the risks and= benefits prior to prescribing BIMZELX. =C2=A0Instruct patients to seek med= ical advice if signs or symptoms suggestive of clinically important infecti= on occur. If a patient develops such an infection or is not responding to s= tandard therapy, monitor the patient closely and do not administer BIMZELX = until the infection 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. =C2=A0If treatment-related increases in liver enzymes occur and drug= -induced liver injury is suspected, interrupt BIMZELX until a diagnosis of = liver injury is excluded. =C2=A0Permanently discontinue use of BIMZELX in p= atients with causally associated combined elevations of transaminases and b= ilirubin. =C2=A0Avoid use of BIMZELX in patients with acute liver disease o= r cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients tr= eated with IL-17 inhibitors, including BIMZELX. =C2=A0Avoid use of BIMZELX = in patients with active IBD. =C2=A0During BIMZELX treatment, monitor patien= ts 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=C2=A0(bimekizumab) EU/EEA* Important Safety Inform= ation^8 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. https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= C2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQ= d4uSQwA6JMudpi5XOwHZtyAHZJBd6YRdp1RSNV5wqOWPREqtju57-2F-2FZ-2FpxzRkIQeA-3D-= 3DZJr4_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0= TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33UB68y= gh0ruRywTiDmGOMH1pAk-2FmoymRIIpemO551vPNmKt1rsmbXWZ1nbo6WZdThfpFvRbPBoFvjqy= CSuuY9CsX6bnCvZ-2FXN8PW0qG6eUfGeH2uleV6-2FIF8qpaYZhD-2BpKg6k7gidJ15oyJf0aJ-= 2Fd4sKBhqeupalROeOOe6JArS-2FB04EgpTsLao-2BG2Xb5UI2e1GJzgOPY8L77Mu-2BdBDgRgj= LSRewq3qdyBoLuzm7LNog-3D Last accessed: April 2024. *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=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 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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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. 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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=C2=A0 1. BIMZELX^=C2=AE (bimekizumab-bkzx) U.S. PI. Available at: https://u706114= 6.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC8ikjD3-2B-2FLu= LRRIcxGl3OVRMld-2BlylPyaHB5-2F88LuoKZ9UGq4aHxAiJW023RnaEtLA-3D-3Dnyg4_2dCLU= NbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6= ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33UB68ygh0ruRywTiDm= GOMH1pAk-2FmoymRIIpemO551vPNmKt1rsmbXWZ1nbo6WZdThfpFvRbPBoFvjqyCSuuY9CqU-2F= 7gc-2FDg90VLDOyk0aTk3quhuZDWaOvVQngeA6EjCOhwZ1boo5w0PDu7xfhTtKd-2B3ln5r0dR0= WmHBXyl-2Bve-2FTYEmVE-2FSQgD7kUTAHTt17x0HBgDWhc-2F9xab202cNARTFk1jVTV5HD4PZ= OlGOMJGHo-3D Last accessed: April 2024. 2. Zouboulis C. 2023, EADV 2023, Oral Presentation # 3262=C2=A0 3. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 20= 12;366(2):158-64. 4. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev= Dis Primers. 2020;6(18):1-20. 5. ClinicalTrials.gov. NCT04242446. 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Available at: https://u7061146.ct.sendg= rid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC8x9ma-2BvZ4KO7y-2BRulIZR= 4pNH3-2B2hSSROKb6YFHfi5re2nCcRr8Q7Zf-2BrIaJ05K9tA-3D-3DMCHz_2dCLUNbuBjhX746= -2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4I= a3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33UB68ygh0ruRywTiDmGOMH1pAk-2= FmoymRIIpemO551vPNmKt1rsmbXWZ1nbo6WZdThfpFvRbPBoFvjqyCSuuY9CsCeStd7S4GODdhT= ZObrUKRtPRcW0w-2BDF746Rd170NPE77asZEz6dIOIicAuJoduY34SNlOmjMu08FWVZTfLZzxLf= uXuxCyoNz1TmRA2PjzbS2sERptLuSixypehNc9AcvctWlHj-2FtjvQpVUo-2FYYcDU-3D Last = accessed date: April 2024. 7. 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. 8. BIMZELX^=C2=AE (bimekizumab) EU SmPC. Available at https://u7061146.ct.s= endgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7= NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZt= yAHZJBd6YRdp1RSNV5wqOW9bXtWvsAqZERe5h1aJ-2FJNQ-3D-3DKpvS_2dCLUNbuBjhX746-2F= vM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3M= TdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33UB68ygh0ruRywTiDmGOMH1pAk-2Fmo= ymRIIpemO551vPNmKt1rsmbXWZ1nbo6WZdThfpFvRbPBoFvjqyCSuuY9CgxD8eBRsrcFK6dQ7Vg= hvzfLXS1-2FCprDTkFSf1e60WJnl4ueEnG23QSUQN7R25bpc-2ByJr8rauzCsQmQiqpcAfBkujW= N23zyyEKc6CwgnIlb-2BsSnMfAUtKnoElEXsW8B-2F8K4SjlvpO22zvoatJRgE-2BN8-3D Last= accessed: April 2024. 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