UCB (EBR:UCB) UCB Media Room: European Commission approval of RYSTIGGO®▼ (rozanolixizumab) for the treatment of adults with generalized myasthenia gravis in Europe

Transparency directive : regulatory news

08/01/2024 07:01

https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6ekOlpMGWbko0Ob8kFTM1AGKneGsl-2Fg90W9R8nnp2HBvZ-2FLhYLWh= yRiyTIT77oBNLtUy2qOE0wg3Q8FRpD3C-2FGo2zaAS_xDPID0vOuylFAU8fv4e60wei4JxqEGBd= VWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ1= 9ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf-2BBZMaGMmI4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9= dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpxkYOJCJczsE3j8YJYAXAlfSSH7ndZGltZpRT1kVrea6= eZiGGkdcaIX71qoI9s6mID7lAczII7gD3l-2F7cxMqW5E2rfX3x4jECtWYDA-2BmlXTmIUO2L6h= 9PpJjRRRxvm3hCF-2F5ImSWJKcyG4xbTgN0j-2BN9VXDO1cp0JKLI-3D ** UCB announces European Commission approval of RYSTIGGO^=C2=AE=E2=96=BC (= rozanolixizumab) for the treatment of adults with generalized myasthenia gr= avis in Europe ------------------------------------------------------------ =C2=B7 European approval of RYSTIGGO=C2=AE (rozanolixizumab) granted as an = add-on to standard therapy for the treatment of generalized myasthenia grav= is (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or an= ti-muscle-specific tyrosine kinase (MuSK) antibody positive^1 =C2=B7 Approval of this orphan medicinal product is based on pivotal Phase = 3 MycarinG study in gMG,^2 which demonstrated that treatment with rozanolix= izumab resulted in statistically significant and clinically meaningful impr= ovements in gMG-specific outcomes compared to placebo,^2 including everyday= activities such as breathing, talking, swallowing, and being able to rise = from a chair^3 =C2=B7 Rozanolixizumab is the first therapy approved in Europe for adults w= ith AChR or MuSK antibody-positive gMG, the two most common subtypes of gMG= =C2=A0 =C2=B7 The decision follows EC approval for UCB=E2=80=99s ZILBRYSQ^=C2=AE= =E2=96=BC (zilucoplan) in Europe for the treatment of adult patients with g= MG, alongside U.S. FDA and Japanese MHLW approvals of rozanolixizumab and z= ilucoplan for the treatment of gMG in adult patients in 2023.^4,5,6,7 =C2=B7 UCB is the first and only company to offer a gMG-focused portfolio, = that provides patients and clinicians the option of targeted therapies for = both anti-AChR and anti-MuSK antibody-positive gMG Brussels (Belgium) 08 January 2024, 07:00 CET =E2=80=93 UCB (Euronext Bruss= els: UCB), a global biopharmaceutical company, today announced that the Eur= opean Commission (EC) has granted a marketing authorization for RYSTIGGO^= =C2=AE (rozanolixizumab) on 5th January 2024 as an add-on to standard thera= py for the treatment of generalized myasthenia gravis (gMG) in adult patien= ts who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyros= ine kinase (MuSK) antibody positive^1. Rozanolixizumab 140 mg/ml solution for injection is a humanized IgG4 monocl= onal antibody that binds to the neonatal Fc receptor (FcRn) resulting in th= e reduction of circulating IgG.^2 It is the first therapy approved in Europ= e for adults with anti-AChR or anti-MuSK antibody-positive gMG, the two mos= t common subtypes of gMG. In December 2023, the EC also granted a marketing authorization for UCB=E2= =80=99s ZILBRYSQ^=C2=AE=E2=96=BC(zilucoplan) as an add-on to standard thera= py for the treatment of gMG in adult patients who are anti-AChR antibody-po= sitive4. Zilucoplan is a once-daily subcutaneously (SC) injected, self-admi= nistered peptide inhibitor of complement component 5 (C5 inhibitor).^8 In progressing a portfolio of medicines for the treatment of gMG, with the = aim of providing HCPs the option of addressing either complement activation= or pathogenic antibodies for appropriate patients, UCB hopes to offer a co= mprehensive portfolio of targeted therapeutics, embodying a commitment to a= ddressing the gMG community=E2=80=99s unmet needs. =E2=80=9CWith the European Commission approval of rozanolixizumab, alongsid= e their recent approval of zilucoplan, I=E2=80=99m very excited that our gM= G portfolio is now approved for use by healthcare professionals across Euro= pe. This represents another important milestone in our ambition to deliver = new and additional patient value to the gMG community and continues our lau= nch trajectory=E2=80=9D, explained Jean-Christophe Tellier, CEO, UCB. =E2= =80=9CWe believe there is still a significant unmet need within the gMG com= munity which can be addressed by bringing differentiated, generally well-to= lerated, and effective treatment options to patients that address key aspec= ts of gMG pathophysiology. We extend our gratitude to the patients, care pa= rtners, and investigators who participated in our clinical studies and who = have shared their insights with us. I would also like to thank our employee= s and collaborators whose dedication, energy and passion have contributed t= o this =C2=A0significant =C2=A0achievement.=E2=80=9D EC approval of rozanolixizumab is supported by safety and efficacy data fro= m the pivotal Phase 3 MycarinG study (NCT03971422), published in The Lancet= Neurology in May 2023.^2 The primary efficacy endpoint was the comparison = of the change from baseline between treatment groups (approximately rozanol= ixizumab 7mg/kg and rozanolixizumab 10mg/kg) versus placebo in the MG-ADL s= core at Day 43. MG-ADL is a measurement tool that assesses the impact of gM= G on daily functions of 8 items that are typically affected in gMG. These i= nclude activities such as breathing, talking, swallowing, and being able to= rise from a chair.^3 Each item is assessed on a 4-point scale where a scor= e of 0 represents normal function and a score of 3 represents loss of abili= ty to perform that function. A total score ranges from 0 to 24, with the hi= gher scores indicating more impairment. Reductions in MG-ADL score from bas= eline to Day 43 were greater in the approximately 7 mg/kg group (least-squa= res mean change =E2=80=933.37 [SE 0.49]) and in the approximately 10 mg/kg = group (=E2=80=933.40 [0.49]) than with placebo (=E2=80=930.78 [0.49]; for 7= mg/kg, least-squares mean difference =E2=88=922.59 [95% CI =E2=88=924.09 t= o =E2=88=921.25], p<0.001; for 10 mg/kg, =E2=88=922.62 [=E2=88=923.99 to = =E2=88=921.16], p<0.001).^1 Secondary efficacy endpoints included change from baseline to Day 43 in the= Myasthenia Gravis Composite (MG-C) and the Quantitative Myasthenia Gravis = (QMC) scores.=C2=A0 The MG-C is a 10-item instrument that measures the symptoms and signs of MG= based on physician examination and patient history. Items are related to p= tosis, double vision, eye closure, talking, chewing, swallowing, breathing,= neck flexion, shoulder abduction, and hip flexion. Each item is scored on = an ordinal scale with four possible categories and weighted. The total scor= e ranges from 0 to 50, with higher scores indicating more severe impairment= s. The MG-C is composed of items originating from other scales (i.e., QMG, = MMT, MG-ADL). A statistically significant difference favoring rozanolixizum= ab compared to placebo was observed in the MG-C score change from baseline = to Day 43 [least squares mean difference] -3.90 (95% CI (=E2=88=926.63 to = =E2=88=921.25), p<0.001 for rozanolixizumab approximately 7mg/kg; least-squ= ares mean difference =E2=88=925.53 (95% CI =E2=88=928.30 to =E2=88=922.97),= p<0.001 for rozanolixizumab approximately 10mg/kg.^1=C2=A0 The QMG is a 13-item categorical grading system that assesses muscle weakne= ss. Each item is assessed on a 4-point scale where a score of 0 represents = no weakness and a score of 3 represents severe weakness. A total possible s= core ranges from 0 to 39, where higher scores indicate more severe impairme= nt.9 A statistically significant difference favoring rozanolixizumab compar= ed to placebo was observed in the QMG total score change from baseline to D= ay 43 [least squares mean difference -3.48 (95% CI (=E2=88=925.61 to =E2=88= =921.58), p<0.001 for rozanolixizumab approximately 7mg/kg; least-squares m= ean difference =E2=88=924.76 (95% CI =E2=88=926.82 to =E2=88=922.86), p<0.0= 01 for =C2=A0rozanolixizumab approximately =C2=A010mg/kg.^1=C2=A0 As included within the rozanolixizumab EU Summary of Product Characteristic= s, the most commonly reported adverse reactions were headache (48.4 %), dia= rrhoea (25.0 %) and pyrexia (12.5 %)^1. gMG is a rare, chronic, heterogeneous, unpredictable autoimmune disease cha= racterized by dysfunction and damage at the neuromuscular junction (NMJ).^1= 0,11,12 gMG has a global prevalence of 100=E2=80=93350 cases per every 1 mi= llion people.^11=C2=A0 This announcement follows approvals of rozanolixizumab and zilucoplan by th= e Japanese Ministry of Health, Labour and Welfare (MHLW) for treatment of g= MG in adult patients (only for patients who inadequately respond to steroid= s or other immunosuppressants), approval of rozanolixizumab by the U.S. Foo= d and Drug Administration (FDA) for the treatment of gMG in adult patients = who are anti-AChR or anti-MuSK antibody positive , and approval of zilucopl= an by the FDA for the treatment of gMG in adult patients who are AChR antib= ody-positive. ^7,5,6 Orphan designation was granted by the European Commission in 2020 to rozano= lixizumab for the treatment of myasthenia gravis and maintained after havin= g received the positive CHMP Opinion.^13=C2=A0 The approval of rozanolixizumab from the EC is valid in all EU member state= s, as well as in the European Economic Area (EEA) countries Iceland, Liecht= enstein, and Norway.=C2=A0 UCB is committed to making rozanolixizumab available to patients as quickly= as possible and anticipates European availability will commence in the fir= st quarter of 2024. =E2=96=BC This medicinal product is subject to additional monitoring. This = will allow quick identification of new safety information. Healthcare profe= ssionals are asked to report any suspected adverse reactions. About rozanolixizumab =C2=B7 Rozanolixizumab 140 mg/ml solution for injection is a subcutaneously= administered, humanized monoclonal antibody that specifically binds to hum= an neonatal Fc receptor (FcRn). It has been designed to block the interacti= on of FcRn and Immunoglobulin G (IgG), accelerating the catabolism of antib= odies and reducing the concentration of pathogenic IgG autoantibodies.^2 =C2=B7 In June 2023, rozanolixizumab-noli was approved by the FDA, for the = treatment of gMG in adult patients who are anti-acetylcholine receptor (ACh= R) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive, having= been granted Priority Review for its Biologic License Application (BLA).^5 =C2=B7 In September 2023, rozanolixizumab was granted approval by the Japan= ese Ministry of Health, Labour and Welfare (MHLW) for the treatment of gene= ralized myasthenia gravis (gMG) in adult patients (only for patients who in= adequately respond to steroids or other immunosuppressants).^7 =C2=B7 Rozanolixizumab is currently under review by the Center of Drug Eval= uation of the China National Medical Products Administration, the Australia= n Therapeutic Goods Administration (TGA), Canada (Health Canada), the Unite= d Kingdom =C2=A0Medicines and Healthcare products Regulatory Agency (MHRA) = and Switzerland (Swissmedic) for the treatment of adults with gMG. Question= s from regulatory agencies to these submissions are expected during H1 2024= .=C2=A0 About zilucoplan =C2=B7 Zilucoplan is a once-daily SC, self-administered peptide inhibitor o= f complement component 5 (C5 inhibitor).=C2=A0 =C2=B7 As the only self-administered C5 inhibitor targeted therapy for gMG,= zilucoplan may inhibit complement-mediated damage to the neuromuscular jun= ction through its targeted mechanism of action.^8 =C2=B7 In September 2023, the Japanese Ministry of Health, Labour and Welfa= re (MHLW) approved zilucoplan for the treatment of gMG in adult patients (o= nly for patients who inadequately respond to steroids or other immunosuppre= ssants).7 =C2=B7 In October 2023, zilucoplan was approved by the U.S. Food and Drug A= dministration (FDA) for the treatment of gMG in adult patients who are anti= -acetylcholine receptor (AChR) antibody positive.^6=C2=A0 =C2=B7 In December 2023, the European Commission granted zilucoplan approva= l as an add-on to standard therapy for the treatment of generalized myasthe= nia gravis (gMG) in adult patients who are anti-acetylcholine receptor (ACh= R) antibody-positive^4 =C2=B7 Zilucoplan is currently under review by the Australian Therapeutic G= oods Administration (TGA), =C2=A0the United Kingdom Medicines and Healthcar= e products Regulatory Agency (MHRA), Canada (Health Canada), South Korea (M= inistry of Food and Drug Safety) and Switzerland (Swissmedic) for the treat= ment of adults with gMG. Questions from regulatory agencies to these submis= sions are expected during H2 2023 and H1 2024. =C2=B7 Orphan designation was granted by the FDA in 2019 to zilucoplan for = the treatment of myasthenia gravis.^14 About generalized Myasthenia Gravis (gMG) gMG is a rare autoimmune disease with a global prevalence of 100=E2=80=9335= 0 cases per every 1 million people.^11 People living with gMG can experienc= e a variety of symptoms, including severe muscular weakness that can result= in double vision, drooping eyelids, difficulty with swallowing, chewing an= d talking, as well as life-threatening weakness of the muscles of respirati= on.^10,15 In gMG, pathogenic autoantibodies can impair synaptic transmission at the n= euromuscular junction (NMJ) by targeting specific proteins on the post-syna= ptic membrane.^16 This disrupts the ability of the nerves to stimulate the = skeletal muscle and results in a weaker contraction. gMG can occur in any r= ace, gender or age.^10,15 About the MycarinG study^2 The MycarinG study (NCT03971422) is a multi-center, Phase 3, randomized, do= uble-blind, placebo-controlled study evaluating the efficacy and safety of = rozanolixizumab in adult patients with gMG, with an open-label extension.= =C2=A0 The primary endpoint for the MycarinG study is change in the Myasthenia Gra= vis-Activities of Daily Living (MG-ADL) score at Day 43, an eight-item pati= ent-reported scale developed to assess MG symptoms and their effects on dai= ly activities. Additional endpoints include changes in the Myasthenia Gravi= s composite (MG-C) score, the Quantitative MG (QMG) score, patient-reported= outcomes at Day 43 and adverse events (AEs). The majority of patients taki= ng part in the MycarinG study opted to enroll in the extensions to this cli= nical trial. As a result, UCB is exploring the potential for further extens= ion studies into this treatment. For more information about the trial, visit https://u7061146.ct.sendgrid.ne= t/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUZDECZjoLWyCfZIxnO42xcxLTM-2B6vXux8o= 66LawS03W8llXDDTf8PxofhyndNyJAPA-3D-3D1mYY_xDPID0vOuylFAU8fv4e60wei4JxqEGBd= VWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ1= 9ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf-2BBZMaGMmI4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9= dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpxkYOJCJczsE3j9K9oZhcEAu-2Fdhr0c8giqDoplmkY8= i3oWEC0bX5h955ogRQ8CaIUSY1Qa1i2494n0EVdG8pzZSssoUh-2BSB5vGpvIiaBbfhM5xWcbnx= xPwsd7WJ1AqHoYmKb5doAo19Zab8hOWbKMdK5zE7Nv9p6FvBE-3D RYSTIGGO^=C2=AE=E2=96=BC (rozanolixizumab) EU/EEA* Important Safety Informa= tion =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.=C2=A0 The most commonly reported adverse reactions were headache (48.4 %), diarrh= oea (25.0 %) and pyrexia (12.5 %). The adverse reactions from the placebo-c= ontrolled study in gMG are as follow : Very common (=E2=89=A5 1/10) headach= e, diarrhoea and pyrexia; Common (=E2=89=A5 1/100 to < 1/10) rash, angioede= ma, arthralgia and injection site reactions. Headache was the most common r= eaction reported in 31 (48.4 %) and 13 (19.4 %) of the patients treated wit= h rozanolixizumab and placebo, respectively. All headaches, except 1 (1.6 %= ) severe headache, =C2=A0were either mild (28.1 % [n=3D18]) or moderate (18= .8 % [n=3D12]) and there was no increase in incidences of headache with rep= eated cyclic treatment. Rozanolixizumab is contra-indicated in patients with hypersensitivity to th= e active substance or to any of the excipients. Treatment with rozanolixizumab in patients with impending or manifest myast= henic crisis has not been studied. The sequence of therapy initiation betwe= en established therapies for MG crisis and rozanolixizumab, and their poten= tial interactions, should be considered. Aseptic meningitis (drug induced aseptic meningitis) has been reported foll= owing rozanolixizumab treatment at a higher dose with subsequent recovery w= ithout sequelae after discontinuation. If symptoms consistent with aseptic = meningitis occur, diagnostic workup and treatment should be initiated as pe= r standard of care. Due to its mechanism of action, the use of rozanolixizumab may increase the= patient=E2=80=99s susceptibility to infections. Treatment with rozanolixiz= umab should not be initiated in patients with a clinically importantactive = infection until the infection is resolved or is adequately treated. During = treatment with rozanolixizumab, clinical signs and symptoms of infections s= hould be monitored. If a clinically important active infection occurs, with= holding rozanolixizumab until the infection has resolved should be consider= ed. =C2=A0 Hypersensitivity reactions including mild to moderate rash or angioedema we= re observed in patients treated with rozanolixizumab. Patients should be mo= nitored during treatment with rozanolixizumab and for 15 minutes after the = administration is complete for clinical signs and symptoms of hypersensitiv= ity reactions. If a hypersensitivity reaction occurs during administration,= rozanolixizumab infusion should be discontinued and appropriate measures s= hould be initiated if needed. Once resolved, administration may be resumed Immunisation with vaccines during rozanolixizumab therapy has not been stud= ied. The safety of immunisation with live or live-attenuated vaccines and t= he response to immunisation with vaccines are unknown. All vaccines should = be administered according to immunisation guidelines and at least 4 weeks b= efore initiation of treatment. For patients that are on treatment, vaccinat= ion with live or live attenuated vaccines is not recommended. For all other= vaccines, they should take place at least 2 weeks after the last infusion = of a treatment cycle and 4 weeks before initiating the next cycle. Please consult the full prescribing information in relation to other side e= ffects, full safety and prescribing information. https://u7061146.ct.sendgr= id.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk5zVHTUB= 0oZtbx-2BjBQB1xq5Ylzg_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-= 2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XK= EBm5Xlxg-2Bf-2BBZMaGMmI4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9dgqIq1qQWyvyKSUBl5rpy= n1TQ1smVNMpxkYOJCJczsE3jwyvY2obqtNPUxbnFjKfs3vGsd94xuCR395zr6o60Ip-2FcgJ-2F= Dn6ZRfpDWyd13b2iOQ8iDXeI-2F5KHgAWq6vxCjdpTueChO4jcsnYBD7sjtZ5E-2BnKSt036Gqx= estM-2FzTeFYgpU84IOo0RR9SuC-2FOzoPRQ-3D For further information, contact UCB:=C2=A0 Global Rare Disease Communications Jim Baxter T+32.2.473.78.85.01=C2=A0 jim.baxter@ucb.com=C2=A0 Corporate Communications, Media Relations Laurent Schots=C2=A0 T+32.2.559.92.64=C2=A0 Laurent.schots@ucb.com=C2=A0 Investor Relations Antje Witte =C2=A0 T +32.2.559.94.14=C2=A0 antje.witte@ucb.com 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= 5.5 billion in 2022. 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: the gl= obal spread and impact of COVID-19, changes in general economic, business a= nd competitive conditions, the inability to obtain necessary regulatory app= rovals or to obtain them on acceptable terms or within expected timing, cos= ts associated with research and development, changes in the prospects for p= roducts in the pipeline or under development by UCB, effects of future judi= cial decisions or governmental investigations, safety, quality, data integr= ity or manufacturing issues; potential or actual data security and data pri= vacy breaches, or disruptions of our information technology systems, produc= t liability claims, challenges to patent protection for products or product= candidates, competition from other products including biosimilars, changes= in laws or regulations, exchange rate fluctuations, changes or uncertainti= es in tax laws or the administration of such laws, and hiring and retention= of its employees. There is no guarantee that new product candidates will b= e discovered or identified in the pipeline, will progress to product approv= al or that new indications for existing products will be developed and appr= oved. Movement from concept to commercial product is uncertain; preclinical= results do not guarantee safety and efficacy of product candidates in huma= ns. So far, the complexity of the human body cannot be reproduced in comput= er models, cell culture systems or animal models. The length of the timing = to complete clinical trials and to get regulatory approval for product mark= eting has varied in the past and UCB expects similar unpredictability going= forward. Products or potential products, which are the subject of partners= hips, joint ventures or licensing collaborations may be subject to differen= ces disputes between the partners or may prove to be not as safe, effective= or commercially successful as UCB may have believed at the start of such p= artnership. UCB=E2=80=99s efforts to acquire other products or companies an= d to integrate the operations of such acquired companies may not be as succ= essful as UCB may have believed at the moment of acquisition. Also, UCB or = others could discover safety, side effects or manufacturing problems with i= ts products and/or devices after they are marketed. The discovery of signif= icant problems with a product similar to one of UCB=E2=80=99s products that= implicate an entire class of products may have a material adverse effect o= n sales of the entire class of affected products. Moreover, sales may be im= pacted by international and domestic trends toward managed care and health = care cost containment, including pricing pressure, political and public scr= utiny, customer and prescriber patterns or practices, and the reimbursement= policies imposed by third-party payers as well as legislation affecting bi= opharmaceutical pricing and reimbursement activities and outcomes. Finally,= a breakdown, cyberattack or information security breach could compromise t= he confidentiality, integrity and availability of UCB=E2=80=99s data and sy= stems.=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 and it does not reflect any potenti= al impact from the evolving COVID-19 pandemic, unless indicated otherwise. = UCB is following the worldwide developments diligently to assess the financ= ial significance of this pandemic to UCB. UCB expressly disclaims any duty = to update any information contained in this press release, either to confir= m the actual results or to report or reflect any change in its forward-look= ing statements with regard thereto or any change in events, conditions or c= ircumstances 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. Rozanolixizumab EU SmPC https://u7061146.ct.sendgrid.net/ls/click?upn=3D= 4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk5qGQoLDP2OY5OwD3tr-2B-2B8BvPg= v_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2F= UwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf-2BBZMaG= MmI4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpxkYOJCJcz= sE3j0Jiu3nof7hgB2JfhJV63KVRWyH17OkM0U94M9lgsfgHVnEBMDPPXuyMeTPmaMKV-2B1kGVP= qpP9wd-2FkfJ2A94xmOUyjRh7m2MRcLUpTjMpWvQFnBr3ktXyIEIb-2FKaLibv3W-2Br5UZ7d33= s26md7BSRhQI-3D Accessed January 2024. 2. Bril V. Efficacy and safety of rozanolixizumab in patients with generali= sed myasthenia gravis: a randomised, double-blind, placebo-controlled, adap= tive Phase 3 study MycarinG study. Lancet Neurol. 2023;22(5):383-94. 3. Wolfe Gl, et al. Myasthenia gravis activities of daily living profile. N= eurology. 1992;52(7):1487-9. 4. Zilucoplan EU SmPC https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED= -2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bb= CZVOamVwH06iqiyz6sAlmQQDlRfCtIrmoCwXX3Ie0snYOwWPtoNzfh1eXH1U9LN61NlG0kfxxA-= 3D-3Dhecw_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulX= MZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf= -2BBZMaGMmI4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpx= kYOJCJczsE3j2UxpPvUN9666-2FZY1q6qwzgHx7TWdAgBHfU9y5N2Xdg4vdTiVpezBF3kugfSpb= ECsPjAjETlL7INH3QvV46iZnHFiuTKM2vV2p1joR2p0uEWuFEWKGxgxtBodHBYwvnQEnzvEqDWq= U4mMfzjsp9LRpE-3D Accessed January 2024. 5. RYSTIGGO^=C2=AE U.S. Prescribing Information https://u7061146.ct.sendgri= d.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUU3jBwLmDbiFJkXyGbslfXWCZMgCTnHf= sVW2mNNh1B9LwmB0RGs5idFkc6Yjt3IvgZz9EcBIBUl8EhfSlw-2FZo53jQLrcRAg-2BBD6gjoX= yF3lmJtZD_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulX= MZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf= -2BBZMaGMmI4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpx= kYOJCJczsE3j0TlL7Gc2EZfOjzpG7suvJVId-2F9-2BchNzdJIN79gI04kqvA7CZ8z5WfcMY2wG= Br5cj8p-2BbnSCx24aM8itAn6-2BolDSKX6mQ3iile4NtAv45SoPm3iPRn3KNYoxob4-2B0Jcrm= -2B7jbdEOzR918AantkG5irY-3D Accessed January 2024. 6. ZILBRYSQ^=C2=AE U.S. Prescribing Information. https://u7061146.ct.sendgr= id.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUU3jBwLmDbiFJkXyGbslfXWCZMgCTnH= fsVW2mNNh1B9LwmB0RGs5idFkc6Yjt3IvgaA8ts1hJd-2FI7KgMfYaMqxkOy6Zhixc7BIQ4NGbl= uuI4MKs8_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXM= ZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf-= 2BBZMaGMmI4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpxk= YOJCJczsE3j2zHc66JA-2FUZ5YV2tPGbQP4BI0fRpnZ8G-2FYCd8rrJTikKgnxnPRXuVqhXl8cd= WayBGhW6eZgBmqeBXkI8mgH3bAANlgkIUPJCNBdczLLpU3-2BmXkYkEeUztlRSUOtpON0crkEoN= Eg9GRx-2B70TKhy9ETM-3D Accessed January 2024 7. Japan MHLW, 25 September 2023. 8. Howard JF Jr, et al. Safety and efficacy of zilucoplan in patients with = generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-= controlled, phase 3 study. Lancet Neurol. 2023;22(5):395-406.=C2=A0 9. Regnault A, et al. Measuring Overall Severity of Myasthenia Gravis (MG):= Evidence for the Added Value of the MG Symptoms PRO. Neurol Ther. 2023; 12= :1573=E2=80=931590.=C2=A0 10. National Institute of Neurological Disorders and Stroke. 2022. Myasthen= ia Gravis Fact Sheet. https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED= -2FM8iDZJQyQ53jATUdtqbkmYH1LTsuAIM5duaf59OidN3dE6GpXMZvh6A0qpERwV7-2FJnLrnB= xcORbHfywyAmxNpNOftw6nzfdIzCpycFlCWVy1FY87Eaz75TcaGVpElWmKINVb-2Bu6HNJG8m2s= AslJ5n2VQ9KFkdddS1qyQLmXFnRWwsZaXCL3m-2BM8Itt-4DB_xDPID0vOuylFAU8fv4e60wei4= JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHM= B7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf-2BBZMaGMmI4ksbuE6OqolsgDK-2BN3zA5D= jfEbQS9dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpxkYOJCJczsE3j2zxPIjXl0A-2Bjc-2FsOl-2= BWjjddX4X2Upn0i3-2FOG7-2BY-2BWqWospBJTQ-2BHAW-2FR5TQdt2tHdijoBHLavnDZBq6xp4= mbzOyFqcDwystWUg2TD-2BbK7aTs8qJt-2FAgbrCc7c5PDfzyjPWqH3paVHvmJWMunU40T7E-3D= Accessed January 2024. 11. Punga AR, et al. Epidemiology, diagnostics, and biomarkers of autoimmun= e neuromuscular junction disorders. Lancet Neurol. 2022;21(2):176-88. 12. Howard JF. Myasthenia gravis: The role of complement at the neuromuscul= ar junction. Ann N Y Acad Sci. 2018;1412:113-128. 13. European Medicines Agency. 2020. EU/3/20/2272: Orphan designation for t= he treatment of myasthenia gravis. https://u7061146.ct.sendgrid.net/ls/clic= k?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk4uDaK9JV4twivvVXkvAlf= 0mfjithKYtlYcnSSTytCIiWGsPCPedFGG72ljeEyNW-2F0Ef19W9DDqNf-2FALutu1r4ItWuV_x= DPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwv= A-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf-2BBZMaGMmI= 4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpxkYOJCJczsE3= jwQi21X7Hs5cNaZ7e7wEcUpJi2HVRorQN50sI8-2FEvwvtM-2FTHyeH46x-2Br5PtbF-2FYlvHw= asRuhtCnsJFjDhUsIgnAC63rfaa2ZFkd4BtRwHmb0pkl4Op-2Bkk6-2FibkP1sqGNOHTWSuhIia= K1tf1y2EkqaZ8-3D Accessed January 2024. 14. US Food and Drug Administration. https://u7061146.ct.sendgrid.net/ls/cl= ick?upn=3D4tNED-2FM8iDZJQyQ53jATUU3jBwLmDbiFJkXyGbslfXW04rSmwBA5m5PfG8B6enR= 3N4PIZ7cI5VzUO5Tl2gmtZI1r-2BhaVXaa-2FF-2FSKzMPBbKdoFFXBiwxYs2-2BTJxMvdj-2Bx= b7y3uCE2ofinqd6VYFTssg-3D-3D0hGk_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI= 08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8= buOLD3011XKEBm5Xlxg-2Bf-2BBZMaGMmI4ksbuE6OqolsgDK-2BN3zA5DjfEbQS9dgqIq1qQWy= vyKSUBl5rpyn1TQ1smVNMpxkYOJCJczsE3j-2Fz-2FhbI-2FKadiko2dRgbWLUiY9HIcK4e-2FM= hxTlZ4iphG4NmIcqXCw9iPuSwem6JoJymJC0GbINykVC0oqXobt1wu98nNT83dzaEI5OiDFxZCy= R4Hs-2F-2FItGiuSn8N6bO1lYnnejjPo8tfE42sN1o8VADs-3D Accessed January 2024. 15. Myasthenia Gravis Foundation of America. MG Quick Facts. https://u70611= 46.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUex4sVwxIFh2EyVoXeK= qyUk2t061R9RR8q9huJ59ECg5HbqcF9RbmPvlEN0DuRUEFA-3D-3DV6uw_xDPID0vOuylFAU8fv= 4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW= 6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg-2Bf-2BBZMaGMmI4ksbuE6OqolsgDK-= 2BN3zA5DjfEbQS9dgqIq1qQWyvyKSUBl5rpyn1TQ1smVNMpxkYOJCJczsE3j1dj39CoZnBDQ0jj= t0nJhGtmvmsCAde9wOeJMuz-2FTJV4XKQw5JQ2yeJcw821PJAWSWKOLTvnGYRYsOTKGkuI0bO3w= VglWYWJRik3CS786gvzMyuLWSR5eyrjExcQxTJP2F677rOBlWY6IJ7kIy6kGa8-3D Accessed = January 2024. 16. Juel VC, Massey JM. Myasthenia gravis. Orphanet J Rare Dis. 2007;2:44. 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