UCB (EBR:UCB) UCB Media Room: European Commission approval of ZILBRYSQ®▼ (zilucoplan) for the treatment of adults with generalized Myasthenia Gravis

Directive transparence : information réglementée

04/12/2023 07:01
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6ena7DqriqA0f3-2Fi1j3-2ByqpgErL7jcFYVuNE1DN5KBDdWt9d-2B0= mCC7pt3aY1ZXBFBc-2BfyR-2FiEP56ZyCTPX4e29DiPPUL_xDPID0vOuylFAU8fv4e60wei4Jxq= EGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7v= QEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg3xnOGuPxX79IRB-2BU7myigy2EPMlM04XfHQAFQbeT= h2ceGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S4PhxLmQsGnr2-2FTO8p1kDzxwzEJuIlKS6IOyt7C= IIriFQSkTDJlSwEmzRtg4DTkBPxL5PvhXb8zsbGgwe6pPnx5WiQs7e4HiiNroX9uJmLQKuCdaiT= 21Q4FXBRqcLfL4HwCdb0WjxrhQgEBrVduH9vi8BDCetalcPGc-3D ** UCB announces European Commission approval of ZILBRYSQ^=C2=AE=E2=96=BC (= zilucoplan) for the treatment of adults with generalized Myasthenia Gravis ------------------------------------------------------------ =C2=B7 European approval of ZILBRYSQ^=C2=AE (zilucoplan) granted as an add-= on to standard therapy for the treatment of generalized Myasthenia Gravis (= gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-= positive1 =C2=B7 Zilucoplan is the first once-daily subcutaneous, targeted C5 complem= ent inhibitor for gMG.^2=C2=A0 =C2=B7 Approval supported by pivotal Phase 3 RAISE study in gMG^2 which dem= onstrated treatment with zilucoplan resulted in statistically significant i= mprovements in MG-specific efficacy outcomes compared to placebo =C2=B7 European approval for zilucoplan follows approvals in U.S. and Japan= earlier in 2023^3,4 =C2=B7 Alongside rozanolixizumab, which was recently approved in U.S. and J= apan for the treatment of gMG,^4,5 and which has received a positive opinio= n from the European Medicines Agency=E2=80=99s Committee for Medicinal Prod= ucts for Human Use (CHMP),^6 zilucoplan is part of UCB=E2=80=99s portfolio = of two different medicines for gMG, each with a distinct mechanism of actio= n and with potential to offer physicians new and additional treatment choic= es =C2=A0 Brussels (Belgium) 4 December 2023, 07:00: (CET) =E2=80=93 UCB (Euronext Br= ussels: UCB), a global biopharmaceutical company, today announced that the = European Commission (EC) has granted a marketing authorization for ZILBRYSQ= ^=C2=AE (zilucoplan) as an add-on to standard therapy for the treatment of = generalized myasthenia gravis (gMG) in adult patients who are anti-acetylch= oline receptor (AChR) antibody-positive.^1=C2=A0 Zilucoplan is the first once-daily subcutaneous (SC), targeted peptide inhi= bitor of complement component 5 (C5) inhibitor for gMG, and the only C5 inh= ibitor approved for self-administration by adult patients with AChR antibod= y-positive gMG.^2=C2=A0 As a C5 inhibitor, zilucoplan inhibits complement-mediated damage to the ne= uromuscular junction through its targeted dual mechanism of action.^2 Benef= its of SC self-injection can include reduced traveling time to and from hos= pitals, decreased interference with work obligations, and increased indepen= dence.^2=C2=A0 Unlike monoclonal antibody C5 inhibitors, as a peptide, zilucoplan can be u= sed concomitantly with intravenous immunoglobulin and plasma exchange, with= out the need for supplemental dosing.^2=C2=A0 The EC approval of zilucoplan is supported by safety and efficacy data from= the RAISE study (NCT04115293), published in The Lancet Neurology in May 20= 23.2 The RAISE study was a multi-center, phase 3, randomized, double-blind,= placebo-controlled study to assess the efficacy, safety profile, and toler= ability of zilucoplan in adult patients with anti-acetylcholine receptor (A= ChR) antibody-positive gMG. Patients were randomized in a 1:1 ratio to rece= ive daily subcutaneous (SC) injections of 0.3 mg/kg zilucoplan or placebo f= or 12 Weeks. The study demonstrated that zilucoplan delivered rapid, consis= tent, clinically meaningful and statistically significant improvements in d= ifferent patient- and clinician-reported outcomes at week 12 in a broad pop= ulation of adult patients with mild-to-severe anti-AChR antibody-positive g= MG.^2 =C2=A0 As included within the zilucoplan EU Summary of Product Characteristics, th= e most frequently reported adverse reactions were injection site reactions = (injection site bruising (13.9%) and injection site pain (7.0%)) and upper = respiratory tract infections (nasopharyngitis (5.2%), upper respiratory tra= ct infection (3.5%) and sinusitis (3.5%)).^1 European approval of zilucoplan follows approvals by the U.S. Food and Drug= Administration (FDA) for the treatment of generalized myasthenia gravis (g= MG) in adult patients who are AChR antibody-positive and by the Japanese Mi= nistry of Health, Labour and Welfare (MHLW) for the treatment of gMG in adu= lt patients who inadequately respond to steroids or other immunosuppressant= s.^3,4 gMG is a rare, chronic, heterogeneous, unpredictable autoimmune disease cha= racterized by dysfunction and damage at the neuromuscular junction (NMJ).^7= ,8,9 Several factors are understood to be drivers of gMG disease pathology,= including the complement cascade, immune cells and pathogenic Immunoglobul= in G (IgG) autoantibodies^10. In AChR antibody-positive gMG, pathogenic AChR autoantibodies (IgG1 and IgG= 3) initiate the classical complement pathway, which, together with the alte= rnative and lectin complement pathways, converge at C5, leading to MAC (mem= brane attack complex) deposition, damage to the NMJ, loss of AChRs and subs= equent impaired synaptic transmission.^9,11 Preventing MAC formation reduce= s damage to the post-synaptic membrane, reduces disruption of ionic channel= conductance and helps to preserve neuromuscular transmission.^11=C2=A0 MG has a global prevalence of 100=E2=80=93350 cases per every 1 million peo= ple.^8 Alongside approval of zilucoplan, UCB=E2=80=99s neonatal Fc receptor (FcRn)= blocker rozanolixizumab recently received a positive opinion from the Euro= pean Medicines Agency=E2=80=99s Committee for Medicinal Products for Human = Use (CHMP) as an add-on to standard therapy for the treatment of generalize= d myasthenia gravis (gMG) in adult patients who are anti-acetylcholine rece= ptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positiv= e.^6 This follows approvals for rozanolixizumab in similar indications in t= he U.S. and Japan earlier this year,^4,5 further strengthening UCB=E2=80=99= s unique gMG portfolio and the company=E2=80=99s commitment to addressing t= he gMG community=E2=80=99s unmet needs. =E2=80=9CWith the European Commission=E2=80=99s approval of zilucoplan I=E2= =80=99m very excited that UCB is taking another important step forward in d= elivering patient value to the gMG community, giving clinicians an opportun= ity to address complement activation in gMG with a once-daily, self-adminis= tered, subcutaneous treatment option. Alongside a positive CHMP opinion fro= m European Medicines Agency for our FcRn blocker rozanolixizumab, and appro= vals for both zilucoplan and rozanolixizumab in the U.S. and Japan for the = treatment of adults with gMG, our unique and differentiated portfolio of me= dicines reinforces our commitment to redefining treatment expectations for = the gMG community,=E2=80=9D explained Jean-Christophe Tellier, CEO, UCB. = =E2=80=9CWe are extremely grateful to the patients, care partners, and inve= stigators who participated in our clinical studies, and to our employees an= d collaborators, whose dedication and passion have made this significant ac= hievement possible.=E2=80=9D The approval of zilucoplan from the EC is valid in all EU member states, as= well as in the European Economic Area (EEA) countries Iceland, Liechtenste= in, and Norway.=C2=A0 UCB is committed to making zilucoplan available to patients as quickly as p= ossible and anticipates European availability will commence in the first qu= arter 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 zilucoplan Zilucoplan is a once-daily SC, self-administered peptide inhibitor of compl= ement component 5 (C5) inhibitor. =C2=A0As the only self-administered C5 in= hibitor targeted therapy for gMG, zilucoplan may inhibit complement-mediate= d damage to the neuromuscular junction through its targeted mechanism of ac= tion.^2=C2=A0 In September 2023 the Japanese MHLW approved zilucoplan for the treatment o= f gMG in adult patients who inadequately respond to steroids or other immun= osuppressants.^4 In October 2023 the U.S. FDA approved zilucoplan for the t= reatment of generalized myasthenia gravis (gMG) in adult patients who are a= nti-acetylcholine receptor (AChR) antibody-positive.^3 Zilucoplan is currently under review by the Australian Therapeutic Goods Ad= ministration (TGA) and Health Canada for the treatment of adults with gMG. = Responses from regulatory agencies to these submissions are expected betwee= n H2 2023 and H2 2024. Orphan designation for zilucoplan was granted by the= FDA in 2019 for the treatment of myasthenia gravis.^12 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.^8 People living with gMG can experience= a variety of symptoms, including severe muscular weakness that can result = in double vision, drooping eyelids, difficulty with swallowing, chewing and= talking, as well as life-threatening weakness of the muscles of respiratio= n.^7,13 In MG, pathogenic autoantibodies can impair synaptic transmission at the ne= uromuscular junction (NMJ) by targeting specific proteins on the post-synap= tic membrane.^14 This disrupts the ability of the nerves to stimulate the m= uscle and results in a weaker contraction. gMG can occur in any race, gende= r or age.^7,13 About the RAISE study^2 The RAISE study (NCT04115293) was a multi-center, Phase 3, randomized, doub= le-blind, placebo-controlled study to confirm the efficacy, safety profile,= and tolerability of zilucoplan in adult patients with anti-acetylcholine r= eceptor (AChR) antibody-positive gMG. Patients were randomized in a 1:1 rat= io to receive daily subcutaneous (SC) injections of 0.3 mg/kg zilucoplan or= placebo for 12 weeks.^2 The primary endpoint for the RAISE study was change from baseline to Week 1= 2 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.^2=C2= =A0 Secondary endpoints included change from baseline in the Quantitative Myast= henia Gravis (QMG) score, the Myasthenia Gravis Composite (MGC) and the Mya= sthenia Gravis Quality of Life 15 revised (MG-QoL15r) score from baseline t= o Week 12, time to first rescue therapy, the proportion of patients with mi= nimal symptom expression (MSE) (defined as MG-ADL of 0 or 1 without rescue = therapy), the proportion with a =E2=89=A53-point reduction in MG-ADL withou= t rescue therapy and the proportion with a =E2=89=A55-point reduction in QM= G without rescue therapy, all measured at Week 12. Safety was assessed by t= he incidence of treatment-emergent adverse events (TEAEs). Patients who com= pleted the RAISE trial had the possibility to enter the open-label extensio= n study, RAISE-XT (NCT04225871).^2=C2=A0 For more information about the trial visit https://u7061146.ct.sendgrid.net= /ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUZDECZjoLWyCfZIxnO42xcxLTM-2B6vXux8o6= 6LawS03W8VL-2BLOFoZ5FJk3mh-2Bt0uydw-3D-3DZO3L_xDPID0vOuylFAU8fv4e60wei4JxqE= GBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQ= EQ19ecNE7nFy8buOLD3011XKEBm5Xlxg3xnOGuPxX79IRB-2BU7myigy2EPMlM04XfHQAFQbeTh= 2ceGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S4PhxLmQsGnr22De4UHzKNVPWnb9l0wjwQgr1wHsVp= O5r6rbEGAwuoRVNDmAJNtt0OuBIKzo6SWldgUrcPs22vroRGMrhuN3kWIOVluvSfglFoEZ0rOul= m9wOpglJeMdqAsF18vXSoVE90hG80wFgeQdWHV-2FUfSf7XM-3D About Rozanolixizumab Rozanolixizumab is a humanized IgG4 monoclonal antibody that binds to the n= eonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.^= 15 It has been designed to block the interaction of FcRn and Immunoglobulin= G (IgG), accelerating the catabolism of antibodies and reducing the concen= tration of pathogenic IgG autoantibodies.^15 In June 2023, rozanolixizumab-noli was approved by the FDA, for the treatme= nt of gMG in adult patients who are anti-acetylcholine receptor (AChR) or a= nti-muscle-specific tyrosine kinase (MuSK) antibody-positive, having been g= ranted Priority Review for its Biologic License Application (BLA).^16=C2=A0 In September 2023 rozanolixizumab was approved by, the Japanese Ministry of= Health, Labour and Welfare (MHLW) for the treatment of gMG in adult patien= ts who inadequately respond to steroids or other immunosuppressants.^4=C2= =A0 In November 2023 rozanolixizumab received a positive opinion from the Europ= ean Medicines Agency CHMP as an add-on to standard therapy for the treatmen= t of generalized myasthenia gravis (gMG) in adult patients who are anti-ace= tylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) a= ntibody-positive.^6 Feedback from the EC on this recommendation is anticipa= ted during Q1 2024.=C2=A0 Rozanolixizumab is also currently under review by the Center of Drug Evalua= tion of the China National Medical Products Administration, the Australian = Therapeutic Goods Administration (TGA), Health Canada and Switzerland (Swis= smedic) for the treatment of adults with gMG. Responses from regulatory age= ncies to these submissions are expected during H2 2023 and H1 2024.=C2=A0 =E2=96=BCZILBRYSQ^=C2=AE (zilucoplan) EU/EEA* Important Safety Information =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. The most frequ= ently reported adverse reactions were injection site reactions (injection s= ite bruising (13.9%) and injection site pain (7.0%)) and upper respiratory = tract infections (nasopharyngitis (5.2%), upper respiratory tract infection= (3.5%) and sinusitis (3.5%)). The adverse reactions from the pooled placeb= o controlled (n=3D115) and open-label extension (n=3D213) studies in gMG ar= e as follows: Very common adverse reactions: (=E2=89=A5 1/10): Upper respir= atory tract infections and Injection site reactions; Common adverse reactio= ns (=E2=89=A5 1/100 to < 1/10) Diarrhoea, Lipase increased, Amylase increas= ed and Morphoea; Uncommon adverse reaction ((=E2=89=A5 1/1000 to < 1/100) b= lood eosinophils increased. Zilucoplan is contra-indicated in patients with= hypersensitivity to the active substance or to any of the excipients, in p= atients who are not currently vaccinated against Neisseria meningitidis and= in patients with unresolved Neisseria meningitidis infection. Due to its m= echanism of action, the use of zilucoplan may increase the patient=E2=80=99= s susceptibility to infections with Neisseria meningitidis. As a precaution= ary measure, all patients must be vaccinated against meningococcal infectio= ns, at least 2 weeks prior to the start of treatment. If treatment needs to= start less than 2 weeks after vaccination against meningococcal infections= , the patient must receive appropriate prophylactic antibiotic treatment un= til 2 weeks after the first vaccination dose. Meningococcal vaccines reduce= but do not completely eliminate the risk of meningococcal infections. Vacc= ines against serogroups A, C, Y, W, and where available, serogroup B, are r= ecommended for preventing the commonly pathogenic meningococcal serogroups.= Vaccination and prophylactic antibiotic treatment should occur according t= o most current relevant guidelines. During treatment, patients should be mo= nitored for signs and symptoms of meningococcal infection and evaluated imm= ediately if infection is suspected. In case of a suspected meningococcal in= fection, appropriate measures such as treatment with antibiotics and discon= tinuation of treatment, should be taken until the meningococcal infection c= an be ruled out. Patients should be instructed to seek immediate medical ad= vice if signs or symptoms of meningococcal infections occur. Prescribers sh= ould be familiar with the educational materials for the management of menin= gococcal infections and provide a patient alert card and patient/carer guid= e to patients treated with zilucoplan. In addition to Neisseria meningitidi= s, patients treated with zilucoplan may also be susceptible to infections w= ith other Neisseria species, such as gonococcal infections. Patients should= be informed on the importance of gonorrhea prevention and treatment. Prior= to initiating zilucoplan therapy, it is recommended that patients initiate= immunizations according to current immunization guidelines. Please consult= the full prescribing information in relation to other side effects, full s= afety and prescribing information. https://u7061146.ct.sendgrid.net/ls/clic= k?upn=3D4tNED-2FM8iDZJQyQ53jATUQ3t-2BHTnJyHgso8CNYFZ-2BqJnr-2FXREj38qS-2B9y= fcbyxJhkj8o_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1Su= lXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg3x= nOGuPxX79IRB-2BU7myigy2EPMlM04XfHQAFQbeTh2ceGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S= 4PhxLmQsGnr22GDRuDSciIFVIh2I6kTGdYw088EUyG4Kt-2F27myXmsBePpep8KqmRYXotZWZXv= H35tZrBmazBzEcMlTsPU-2Fp7SeV4clc5q8cLmvANhSo8FWIcURuzN1-2FMwUjDQOgnHkbaE7Q6= fqjjzieHHzHQoMV51E-3D EC Date of approval 01 Dec 2023. 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. 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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:=C2=A0 1. Zilucoplan EU SmPC https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED= -2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk5qGQoLDP2OY5OwD3tr-2B-2B8BpF2N_xDP= ID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-= 2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg3xnOGuPxX79IRB-2B= U7myigy2EPMlM04XfHQAFQbeTh2ceGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S4PhxLmQsGnr263T= tzq3tjYVUf9wICuNzkEdIv7RWT-2BBUqhLpC-2BrbUgyMu-2BrmCO5I-2Bv8RhbnoHz73tt-2FP= IBCzM0R8It5iHH9iYFycOyDhZlCaBBv9Gj1JUC4hy8kMZNwZqA7uVTsZMi1k2twpPg6fMEIw3JU= WoBQP3I-3D Accessed December 2023. 2. 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 3. ZILBRYSQ^=C2=AE U.S. Prescribing Information. https://u7061146.ct.sendgr= id.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUU3jBwLmDbiFJkXyGbslfXWCZMgCTnH= fsVW2mNNh1B9LwmB0RGs5idFkc6Yjt3IvgaA8ts1hJd-2FI7KgMfYaMqxkOy6Zhixc7BIQ4NGbl= uuI4Rhk0_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXM= ZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg3xnOG= uPxX79IRB-2BU7myigy2EPMlM04XfHQAFQbeTh2ceGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S4Ph= xLmQsGnr23-2FK1gXtbBSx2-2Bm4RNS8GynquljINqFQQkNY8MAnwznQpFNDGpNiW3iEQrRKsiN= sMAw3G2S80JcOCKQ9Ynp5EZeF3KUuAaso1ZDwJBrYKL5GtOeky19IFVoxTe-2FJPnTj1tspIJdP= FBqb5cqjFjcDYz8-3D Accessed December 2023. 4. Data on file: Japan MHLW, 25 September 2023. 5. Rozanolixizumab-noli FDA approval. https://u7061146.ct.sendgrid.net/ls/c= lick?upn=3D4tNED-2FM8iDZJQyQ53jATUU3jBwLmDbiFJkXyGbslfXWCZMgCTnHfsVW2mNNh1B= 9LwmB0RGs5idFkc6Yjt3IvgZz9EcBIBUl8EhfSlw-2FZo53jQLrcRAg-2BBD6gjoXyF3lmtmSQ_= xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUw= vA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg3xnOGuPxX79IRB= -2BU7myigy2EPMlM04XfHQAFQbeTh2ceGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S4PhxLmQsGnr2= y462kZK-2BzFKMI56XtVj2akLnBAyltjnc5x30bYCNmUu9CQ01Qz2dgY4NRYfsNSnjS2KuosiY0= 3zWmquULRgSnQBkrnmS1IjOyW0C7Q4JTWjUt5k9YrGaM0kuWaK1zKV6OGL5I-2BiuNkj0mYl1WM= 0fl8-3D Accessed December 2023. 6. EMA CHMP rozanolixizumab positive opinion. https://u7061146.ct.sendgrid.= net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk4uDaK9JV4t= wivvVXkvAlf0-2B912RF-2BkL4irPgDzh4WeBIH0B1tsXEnlca1Vr-2BxCzgxMn-2FX5bJryP-2= BDGmOXEJVS2WtZKGnex4fdpv16WagFQgQ-3D-3DcB7J_xDPID0vOuylFAU8fv4e60wei4JxqEGB= dVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ= 19ecNE7nFy8buOLD3011XKEBm5Xlxg3xnOGuPxX79IRB-2BU7myigy2EPMlM04XfHQAFQbeTh2c= eGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S4PhxLmQsGnr26Y9ESETRGwQwwYYm-2BBrpRB2xF-2BO= -2FaEms5YHm2V-2BM9XXCD6PLph-2F5RtFdH7tWG-2BCEXuhf-2BwoBwIYaVo5laXAtQlOORZw6= 8Bvo2Rgw6pR01F0CiXiN4OfjetlnQgSIJypSO-2FAfdyVjQMBPoniNj7F92U-3D Accessed De= cember 2023. 7. National Institute of Neurological Disorders and Stroke. 2022. Myastheni= a Gravis Fact Sheet. https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-= 2FM8iDZJQyQ53jATUdtqbkmYH1LTsuAIM5duaf711KyE-2F-2Bsc1oMjvvBJ4IPMmDQTJO6RQ3Q= Obo-2Bs7gEWDg-3D-3DsjsJ_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwO= r-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011= XKEBm5Xlxg3xnOGuPxX79IRB-2BU7myigy2EPMlM04XfHQAFQbeTh2ceGTHdakIPhUOuKkN-2Bw= bIJ0v9c3El5S4PhxLmQsGnr2-2Bm2ci63IGuIEGinToscNzP6haKovmNpBPEfdyfg8CZ6HpBDY6= GngHPBiu9oFzt4-2FQ-2BbSsrxVP-2FEvNovJirjnozwvtWUWCE0O1R1zBWWQWbM2pSqlum-2FQ= 7iY-2Bnny-2BXC8ZVG8BttPBJ71I4uB-2B9IRLVA-3D Accessed December 2023. 8. Punga AR, et al. Epidemiology, diagnostics, and biomarkers of autoimmune= neuromuscular junction disorders. Lancet Neurol. 2022;21(2):176-88. 9. Howard JF Jr. Myasthenia gravis: The role of complement at the neuromusc= ular junction. Ann N Y Acad Sci. 2018;1412(1):113=E2=80=9228.=C2=A0 10. Phillips WD, Vincent A. Pathogenesis of myasthenia gravis: Update on di= sease types, models, and mechanisms. F1000Res. 2016;5:F1000 Faculty Rev-151= 3. 11. Mantegazza R, et al. Complement inhibition for the treatment of myasthe= nia gravis. Immunotargets Ther. 2020;9:317=E2=80=9331. 12. US Food and Drug Administration. https://u7061146.ct.sendgrid.net/ls/cl= ick?upn=3D4tNED-2FM8iDZJQyQ53jATUU3jBwLmDbiFJkXyGbslfXW04rSmwBA5m5PfG8B6enR= 3N4PIZ7cI5VzUO5Tl2gmtZI1r-2BhaVXaa-2FF-2FSKzMPBbKdoFFXBiwxYs2-2BTJxMvdj-2Bx= b7y3uCE2ofinqd6VYFTssg-3D-3Dmrdb_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI= 08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8= buOLD3011XKEBm5Xlxg3xnOGuPxX79IRB-2BU7myigy2EPMlM04XfHQAFQbeTh2ceGTHdakIPhU= OuKkN-2BwbIJ0v9c3El5S4PhxLmQsGnr28WiiVTKIWDSWKAbOJi6xijdEBzcr-2FP0gcMn4uE4u= LzqVY3sF7BK-2B54cypYfILb6fXeTzWyTm22Y6Q4uM5dCnPpexHza8-2FwtebOUrdAhtDAU161Q= RHROIC-2BNuiNyrpev-2BTeajO4S1-2FsDiFJj5JgPR8c-3D Accessed October 2023. 13. Myasthenia Gravis Foundation of America. MG Quick Facts. https://u70611= 46.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUex4sVwxIFh2EyVoXeK= qyUk2t061R9RR8q9huJ59ECg5HbqcF9RbmPvlEN0DuRUEFA-3D-3DOFXy_xDPID0vOuylFAU8fv= 4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW= 6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg3xnOGuPxX79IRB-2BU7myigy2EPMlM0= 4XfHQAFQbeTh2ceGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S4PhxLmQsGnr2xc3LcS4vMoG0HEGoh= ipb5w-2Bc2mUcHW0kvR9ujGFx9DoPfadLsWvafvpGptt9yzplxheOpo4RDshSqnhuTldoapyVJ-= 2BOZbkcIKFk9MMe6AUyiaMOKnjXR2TCZKdwd9flR72kg-2Bw1MQZZ6Pr-2FC3orKsY-3D Acces= sed December 2023. 14. Juel VC, Massey JM. Myasthenia gravis. Orphanet J Rare Dis. 2007;2:44. 15. Bril V, et al. Safety and efficacy of rozanolixizumab in patients with = generalised myasthenia gravis (MycarinG): a randomised, double-blind, place= bo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-94. 16. RYSTIGGO^=C2=AE U.S. Prescribing Information: https://u7061146.ct.sendg= rid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUe05JLfJB1cEr6yIYPHeiahNq-2BFs= 5JzTJ6fbJleHgZPzSHtBcRUVqc0LfD59HP53hg59FBzcN8OYLwqq5F2g3Wo-3DAwL6_xDPID0vO= uylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPs= k4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg3xnOGuPxX79IRB-2BU7myi= gy2EPMlM04XfHQAFQbeTh2ceGTHdakIPhUOuKkN-2BwbIJ0v9c3El5S4PhxLmQsGnr277SxPoAo= NwFBgzCLnRsDBfW1EMZixUzuhzXxxGCQjd478KA0CYE-2B2XyMed7xZxHfCIJuoevPXAHKraSu3= zGOIloo0F-2BPyW48Hw9zM9LL2giuJr7csG10riLqU1UjcXDJOyePS4Z2lnzAroigPTc6DM-3D = Accessed December 2023. 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