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UCB (EBR:UCB) UCB Media Room: UCB presents latest data from generalized myasthenia gravis portfolio at AANEM meeting

Directive transparence : information réglementée

22/09/2022 07:00
https://mb.cision.com/Public/18595/3634655/97a5454c47e4c409_800x800ar.png ** UCB presents latest data from generalized myasthenia gravis portfolio at= AANEM meeting ------------------------------------------------------------ =C2=B7 Results presented across UCB=E2=80=99s generalized myasthenia gravis= (gMG) development program builds the body of evidence around the complexit= ies of gMG=C2=A0 =C2=B7 Presentations to include data from the Phase 3 MycarinG study of roz= anolixizumab as well as the Phase 3 RAISE and RAISE-XT studies of zilucopla= n Brussels (Belgium), 22 September 2022 =E2=80=93 7:00 (CEST) =E2=80=93 UCB, = a global biopharmaceutical company, announced today it is presenting result= s from across its portfolio in generalized myasthenia gravis (gMG) at the A= merican Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) a= nnual meeting featuring the Myasthenia Gravis Foundation of America (MGFA) = Scientific Session, September 21 =E2=80=93 24. Presentations include study = results for its investigational treatments, zilucoplan, a self-administered= , subcutaneous (SC) peptide inhibitor of complement component 5 (C5 inhibit= or) and rozanolixizumab, an SC-infused monoclonal antibody targeting the ne= onatal Fc receptor (FcRn), in adults with gMG. In addition, the company is = also presenting real-world findings into the burden of the disease for soci= ety and the potential role of a digital application in improving care.=C2= =A0 The safety and efficacy of rozanolixizumab and zilucoplan have not been est= ablished and neither treatment is approved for use in any indication by any= regulatory authority worldwide. =E2=80=9CPatients living with gMG experience high disease and treatment bur= den resulting in a significant impact on their daily lives. The data being = presented at AANEM and the MG Scientific Session reinforce the potential of= UCB=E2=80=99s two investigational medicines with different mechanisms of a= ction to provide targeted treatment options to patients,=E2=80=9D said Iris= Loew-Friedrich, Executive Vice President and Chief Medical Officer at UCB.= =E2=80=9CWe are committed to meeting patients=E2=80=99 needs, regardless o= f antibody profile, including those with MuSK Ab+ gMG who have particularly= limited treatment options. With our gMG pipeline, we hope to address both = drivers of disease pathology and which account for approximately 95% of pat= ients living with gMG.=E2=80=9D Rozanolixizumab MycarinG Phase 3 Results A subgroup analysis presented from the Phase 3 MycarinG study (Poster 16, M= GFA Scientific Session)^1=C2=A0 =C2=A0analyzes the efficacy of rozanolixizu= mab in patients with muscle specific kinase antibody-positive (MuSK-Ab+) gM= G, which is often more severe and harder to treat than acetylcholine recept= or antibody positive (AChR-Ab+) gMG.^2 In the analysis, rozanolixizumab dem= onstrated statistically significant and clinically meaningful improvements = in MG-specific outcomes in patients with MuSK-Ab+ gMG, that were consistent= with results in AChR-Ab+ gMG and the overall population. Improvements in M= yasthenia Gravis-Activities of Daily Living (MG-ADL) score for the overall = population (n=3D200), including MuSK-Ab+ patients, were -3.37 for 7mg/kg (n= =3D66; 5 MuSK Ab+) and -3.40 for 10mg/kg (n=3D67) vs -0.78 (n=3D67) for pla= cebo. In the MuSK-Ab+ specific subgroup, improvement in MG-ADL was =E2=80= =937.28 (7mg/kg; n=3D5), =E2=80=934.16 (10mg/kg; n=3D8), and 2.28 (placebo;= n=3D8). In the AChR-Ab+ specific subgroup, improvement in MG-ADL was =E2= =80=933.03 (7mg/kg; n=3D60), =E2=80=933.36, (10mg/kg; n=3D60), and =E2=80= =931.10 (placebo; n=3D59).^1 In a responder analysis from MycarinG (Poster 204, AANEM)^3, results presen= ted demonstrated that rozanolixizumab significantly reduced MG-ADL from bas= eline to Day 43. In this primary endpoint, rozanolixizumab showed an LS mea= n difference vs placebo of 2.59 points at the 7mg/kg dose and 2.62 points a= t the 10mg/kg dose. Furthermore, a greater percentage of patients in the ro= zanolixizumab 7mg/kg and 10mg/kg arms than the placebo arm achieved a 2.0-p= oint or greater improvement in MG-ADL, a 3.0-point or greater improvement i= n Quantitative Myasthenia Gravis (QMG) scores and a 3.0-point or greater im= provement in Myasthenia Gravis Composite (MGC) scores. Rozanolixizumab had = an acceptable safety profile and was generally well tolerated with similar = occurrences of TEAEs between both doses.^3 A further safety analysis of the MycarinG trial (Oral presentation, =E2=80= =98Clinical Trials 2=E2=80=99 session, MGFA Scientific Session),^4 showed t= hat rozanolixizumab was generally well tolerated, with the majority of trea= tment emergent adverse events (TEAEs) being mild to moderate in severity. A= higher proportion of TEAEs occurred in the active treatment arms versus pl= acebo (81.3% for 7 mg/kg, 82.6% for 10 mg/kg and 67.2% for placebo) and wer= e comparable between the rozanolixizumab groups. The most frequently report= ed TEAEs were headache, diarrhea, pyrexia and nausea. A higher incidence of= headache was reported in the rozanolixizumab groups versus placebo, with m= ost cases mild to moderate and severe cases generally managed with non-opio= id analgesics. There were no severe or serious infections in the rozanolixi= zumab groups. Treatment withdrawal due to TEAEs was low; the rate was simil= ar in the rozanolixizumab 7 mg/kg and placebo groups and higher in the roza= nolixizumab 10 mg/kg group.^4=C2=A0 Zilucoplan Phase 3 RAISE and RAISE-XT Results An interim analysis from RAISE-XT (data cut off 18 February 2022), a Phase = 3, multicenter, open-label extension study (Poster 14, MGFA Scientific Sess= ion) is also being presented.^5=C2=A0This ongoing study recruited patients = with AChR-Ab+ gMG who participated in randomized Phase 2 (NCT03315130) and = Phase 3 (NCT04115293) zilucoplan studies. Building on the data seen in the = double-blind Phase 2 and Phase 3 studies, results demonstrated a favorable = long-term safety profile for zilucoplan over 24 weeks with no major safety = findings, with efficacy in patients who had previously received zilucoplan = continuing to improve, and efficacy demonstrated as early as week 1 in pati= ents who switched from placebo. At extension study Week 12, after 24 weeks,= the zilucoplan group achieved an LS =C2=A0mean improvement in MG-ADL score= from the double-blind study baseline of =E2=88=926.30. MG-ADL improvement = for the placebo-switch group, after 12 weeks of zilucoplan, was =E2=88=926.= 32.=C2=A0 A presentation on the quality-of-life (QoL) outcomes with zilucoplan from t= he Phase 3 RAISE study (NCT04115293) (Oral presentation, =E2=80=98Clinical = Trials 2=E2=80=99 session, MGFA Scientific Session)^6 demonstrated that zil= ucoplan clinically meaningfully and highly statistically significantly impr= oved MG-ADL at week 12 (LS mean difference v placebo =E2=80=932.09; p<0.001= ) and showed consistently greater improvement in fatigue vs placebo (LS mea= n difference vs placebo at Week 12, =E2=80=933.06; nominal p=3D0.0069). An = overall Work Impairment due to problem score with zilucoplan vs placebo (LS= mean difference vs placebo =E2=80=9312.83; p=3D0.0912) was also observed. = Zilucoplan demonstrated a favorable safety profile, with a similar rate of = TEAEs between zilucoplan (76.7%) and placebo (70.5%), and good tolerability= . The most common TEAEs were injection-site reactions (26.7% zilucoplan vs = 14.8% placebo); all were non-serious, and mild in severity, except for one = instance of injection-site pain of moderate severity in the zilucoplan grou= p and no patients discontinued due to an injection-site reaction. All patie= nts in the zilucoplan arm who completed the 12-week treatment period have e= ntered the ongoing RAISE-XT extension study (NCT04225871).=C2=A0 Additionally, in a detailed responder analysis from Phase 3 RAISE trial bei= ng presented (Poster 200, AANEM)^7 significantly higher proportions of pati= ents receiving zilucoplan achieved =E2=89=A53-point and =E2=89=A55-point im= provements in MG-ADL and QMG without rescue therapy vs placebo, respectivel= y Zilucoplan demonstrated a clinically meaningful placebo-corrected mean im= provement of 2.09 points (p<0.001) in MG-ADL, with 73.1% (p<0.001) of patie= nts receiving zilucoplan achieving a 3.0-point or greater reduction in MG-A= DL compared to placebo (46.1%) and 58% (p=3D0.0012) of patients receiving z= ilucoplan achieving a 5.0-point or greater reduction in QMG compared to pla= cebo (33.3%). Zilucoplan had a favorable safety profile with no major safet= y findings and good tolerability.^7 Real-world costs of gMG and digital application supporting patients =C2=A0 Data from a study exploring the health care utilization and societal costs = of MG in Norway (Poster 9, MGFA Scientific Session)^8 highlighted the burde= n on both patients and society. It showed that societal costs such as lost = life years, QoL, and productivity are significant and greater than direct t= reatment-related costs (estimated to be only 11.5% of societal costs).=C2= =A0 A further study on the real-world assessment of patient perceptions on an M= G symptom-tracking application^9 showed the potential of the smartphone app= lication to equip patients with information that would allow them to better= communicate their individual disease experience to their healthcare profes= sional while also making behavioral changes to better manage their disease.= Further assessment of this application is underway. (Oral presentation, = =E2=80=98Outcomes=E2=80=99 session, MGFA Scientific Session).=C2=A0 =E2=80=9CWe are proudly and firmly committed to supporting the gMG communit= y by increasing knowledge and understanding of the true burden of this dise= ase to help improve outcomes,=E2=80=9D said Charl van Zyl, Executive Vice P= resident Neurology & Head of Europe/International Markets at UCB. =E2=80=9C= By focusing on patients and reinforcing our gMG pipeline with a platform of= support services and digital innovations, we aim to transform the lives of= people living with this disease.=E2=80=9D=C2=A0 UCB anticipates filing regulatory submissions in the European Union, Japan = and the U.S. for both zilucoplan and rozanolixizumab later this year. For further information, contact UCB:=C2=A0 Brand Communications, Rare Diseases 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 =C2=A0 =C2=A0 =C2=A0=C2=A0 T +32.2.559.94.14=C2=A0 antje.witte@ucb.com About Generalized Myasthenia Gravis (gMG) Myasthenia gravis is a rare disease impacting almost 200,000 patients in th= e U.S., EU and Japan.^10,11=C2=A0 People living with gMG can experience a v= ariety of symptoms, including drooping eyelids, double vision and difficult= y swallowing, chewing and talking, as well as severe muscular weakness that= can result in life threatening weakness of the muscles of respiration.^12= =C2=A0=C2=A0 gMG is a chronic and unpredictable auto-immune disease in which pathogenic = autoantibodies can inhibit synaptic transmission at the neuro-muscular junc= tion by targeting specific proteins on the post-synaptic membrane. This dis= rupts the ability of the nerves to stimulate the muscle and results in a we= aker contraction.^13 gMG can occur at any age and in any race, although pre= vious studies have shown that women are more often impacted than men.^12 Mo= st patients with gMG have pathogenic IgG antibodies that disrupt the transm= ission of nerve impulses to muscles in the NMJ and some activate the comple= ment cascade. Complement-mediated destruction via MAC formation is a key me= chanism causing damage at the NMJ and is the key driver of disease in AChR = Ab+ gMG. About the zilucoplan RAISE study^14 The RAISE study (NCT04115293) is a multi-center, Phase 3, randomized, doubl= e-blind, placebo-controlled study to confirm the efficacy, safety, and tole= rability of zilucoplan in patients with gMG. Patients were randomized in a = 1:1 ratio to receive daily subcutaneous (SC) doses of 0.3 mg/kg zilucoplan = or placebo for 12 weeks. The primary endpoint for the RAISE study is change from baseline to Week 12= in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score. Second= ary endpoints include change in the Quantitative Myasthenia Gravis (QMG) sc= ore, the Myasthenia Gravis Composite (MGC) and the Myasthenia Gravis Qualit= y of Life 15 revised (MG-QoL15r) score from baseline to Week 12, time to re= scue therapy, the proportion with minimal symptom expression (MSE) (defined= as MG-ADL of 0 or 1), the proportion with a =E2=89=A53-point reduction in = MG-ADL and the proportion with a =E2=89=A55-point reduction in QMG, all mea= sured at Week 12. Secondary safety endpoint is incidence of TEAEs. Patients= who completed the RAISE trial had the possibility to enter the open label = extension study, RAISE-XT (NCT04225871).=C2=A0 For more information about the trial visit https://clinicaltrials.gov/ct2/s= how/NCT04115293.=C2=A0 About the rozanolixizumab MycarinG study^15=C2=A0 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, an eight-item patient-report= ed scale developed to assess MG symptoms and their effects on daily activit= ies. Additional endpoints include response rates, changes in the Myasthenia= Gravis composite (MGC) score, the Quantitative MG (QMG) score, patient-rep= orted outcomes and adverse events (AEs). The majority of patients taking pa= rt in the MycarinG study opted to enroll in the open label extensions to th= is clinical trial. As a result, UCB is exploring the potential for further = extension studies into this treatment. For more information about the trial, visit https://clinicaltrials.gov/ct2/= show/NCT03971422.=C2=A0 About Zilucoplan=C2=A0 Zilucoplan is a once-daily self-administered SC peptide inhibitor of comple= ment component 5 (C5 inhibitor) under clinical development by UCB in gMG. R= esults from the RAISE study, a multi-center, Phase 3, randomized, double-bl= ind, placebo-controlled study demonstrated the efficacy, safety, and tolera= bility of zilucoplan in patients with gMG, and regulatory submissions are p= lanned in 2022. In 2019, the US FDA granted orphan drug designation to zilu= coplan for the treatment of myasthenia gravis.^16 Orphan designation was gr= anted in 2022 by the European Commission to zilucoplan for the treatment of= myasthenia gravis.^17 The safety and efficacy of zilucoplan have not been established and it is n= ot currently approved for use in any indication by any regulatory authority= worldwide. About Rozanolixizumab Rozanolixizumab is an SC administered, humanized monoclonal antibody that s= pecifically binds, with high affinity, to human neonatal Fc receptor (FcRn)= . It has been designed to block the interaction of FcRn and Immunoglobulin = G (IgG), accelerating the catabolism of antibodies and reducing the concent= ration of pathogenic IgG autoantibodies.^18,19 Rozanolixizumab is under clinical development with the aim of improving the= lives of people with pathogenic IgG-autoantibody-driven autoimmune disease= s. In 2019, the US FDA granted orphan drug designation to rozanolixizumab f= or the treatment of myasthenia gravis.^20 Orphan designation was granted in= 2020^21 by the European Commission for rozanolixizumab for the treatment o= f myasthenia gravis. The safety and efficacy of rozanolixizumab have not been established and it= is not approved for use in any indication by any regulatory authority worl= dwide. About UCB in Rare Diseases=C2=A0 At UCB, we don=E2=80=99t just see patients or population sizes, we see peop= le in need. Through decades of serving the neurology and immunology communi= ties, we have improved lives with impactful medicines and by enhancing the = social and emotional well-being of patients. As a continuation of our herit= age, we are now expanding our efforts to tackle rare neurological and immun= ological diseases where current options offer little hope, including invest= igational treatments for gMG, MOG-AD and AIE. 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 more than 7,600 people in= approximately 40 countries, UCB generated revenue of =E2=82=AC5.3 billion = in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twi= tter: @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 partnersh= ips, joint ventures or licensing collaborations may be subject to differenc= es 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 pa= rtnership. UCB=E2=80=99 efforts to acquire other products or companies and = to integrate the operations of such acquired companies may not be as succes= sful as UCB may have believed at the moment of acquisition. Also, UCB or ot= hers could discover safety, side effects or manufacturing problems with its= products and/or devices after they are marketed. The discovery of signific= ant problems with a product similar to one of UCB=E2=80=99s products that i= mplicate an entire class of products may have a material adverse effect on = sales of the entire class of affected products. Moreover, sales may be impa= cted by international and domestic trends toward managed care and health ca= re cost containment, including pricing pressure, political and public scrut= iny, customer and prescriber patterns or practices, and the reimbursement p= olicies imposed by third-party payers as well as legislation affecting biop= harmaceutical pricing and reimbursement activities and outcomes. Finally, a= breakdown, cyberattack or information security breach could compromise the= confidentiality, integrity and availability of UCB=E2=80=99s data and syst= ems. 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. 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= =C2=A0the registration or qualification under the securities laws of such j= urisdiction. References 1. Habib AA, et al. Efficacy of rozanolixizumab in muscle-specific kinase a= ntibody-positive generalized myasthenia gravis: Outcomes from the randomize= d, Phase 3 MycarinG study. Poster 16, MGFA Scientific Session, AANEM 2022. 2. Rodolico C, et al. MuSK-Associated Myasthenia Gravis: Clinical Features = and Management. Front Neurol. 2020;11:660=C2=A0 =C2=A0 3. Bril V, et al. Rozanolixizumab in generalized myasthenia gravis: Respond= er analyses from the Phase 3 MycarinG study. Poster 204, AANEM 2022. 4. Vu T, et al. Safety and tolerability of rozanolixizumab in the randomize= d Phase 3 MycarinG study. Oral presentation, MGFA Scientific Session at AAN= EM 2022.=C2=A0 5. Genge A, et al. Safety and tolerability of zilucoplan in RAISE-XT: A mul= ticenter, open-label extension study in patients with generalized myastheni= a gravis. Poster 14, MGFA Scientific Session, AANEM 2022.=C2=A0 6. Weiss MD, et al, Quality of life outcomes in RAISE: A double-blind rando= mized, placebo-controlled study of zilucoplan in gMG. Oral presentation. MG= FA Scientific Session, AANEM 2022.=C2=A0 7. Vu T, et al. Efficacy and safety of zilucoplan in myasthenia gravis: Res= ponder analysis from the randomized Phase 3 RAISE trial. Poster 200, AANEM = 2022. 8. Bugge C, et al. Burden of myasthenia gravis: Health care utilization and= societal costs in Norway. Poster 9, MGFA Scientific Session, AANEM 2022.= =C2=A0 9. Steels J-C, et al. Improving outcomes by tracking symptoms, triggers and= quality of life. Real-world assessment and patient perceptions of a protot= ype myasthenia gravis tracking app. Oral presentation. MGFA Scientific Sess= ion, AANEM 2022. 10. Chen J, et al. Incidence, mortality, and economic burden of myasthenia = gravis in China: A nationwide population-based study. Lancet Reg Health Wes= t Pac. 2020;5:100063. 11. Gilhus N. Myasthenia Gravis. N Engl J Med. 2016;375:2570-2581. 12. Hansen JS, et al. Mortality in myasthenia gravis: A nationwide populati= on-based follow-up study in Denmark. Muscle Nerve. 2016;53:73-77. 13. Myasthenia Gravis Foundation of America. Clinical Overview of MG. https= ://myasthenia.org/Professionals/Clinical-Overview-of-MG. Accessed August 20= 22. 14. ClinicalTrials.gov =E2=80=98Safety, Tolerability, and Efficacy of Ziluc= oplan in Subjects With Generalized Myasthenia Gravis (RAISE)=E2=80=99: http= s://clinicaltrials.gov/ct2/show/NCT04115293. Accessed August 2022. 15. ClinicalTrials.gov =E2=80=98A Study to Test Efficacy and Safety of Roza= nolixizumab in Adult Patients With Generalized Myasthenia Gravis=E2=80=99: = =C2=A0https://clinicaltrials.gov/ct2/show/NCT03971422. Accessed August 2022= . 16. US Food and Drug Administration.https://www.accessdata.fda.gov/scripts/= opdlisting/oopd/detailedIndex.cfm?cfgridkey=3D699319. Accessed August 2022.= =C2=A0 17. Data on file. 18. Kiessling P, et al. The FcRn inhibitor rozanolixizumab reduces human se= rum IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017;9(4= 14). 19. Smith B, et al. Generation and characterization of a high affinity anti= -human FcRn antibody, rozanolixizumab, and the effects of different molecul= ar formats on the reduction of plasma IgG concentration. MAbs.2018;10:1111-= 1113. 20. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts= /opdlisting/oopd/detailedIndex.cfm?cfgridkey=3D669918. Accessed August 2022 21. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human= /orphan-designations/eu3202272. Accessed August 2022=C2=A0 GenericFile AANEM Data Presentations Press Release FINAL 22 Sept 2022 ENG (https://mb.c= ision.com/Public/18595/3634655/8c95ab8230ffb318.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x116625x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium