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
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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=
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roducts in the pipeline or under development by UCB, effects of future judi=
cial decisions or governmental investigations, safety, quality, data integr=
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e discovered or identified in the pipeline, will progress to product approv=
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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=
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UCB is providing this information, including forward-looking statements, on=
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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-=
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rid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUe05JLfJB1cEr6yIYPHeiahNq-2BFs=
5JzTJ6fbJleHgZPzSHtBcRUVqc0LfD59HP53hg59FBzcN8OYLwqq5F2g3Wo-3DAwL6_xDPID0vO=
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Accessed December 2023.
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