https://mb.cision.com/Public/18595/3841624/aabfbc07c8c57524_800x800ar.png
** UCB announces approval of RYSTIGGO^=C2=AE (rozanolixizumab) and ZILBRYSQ=
^=C2=AE (zilucoplan) for the treatment of adult patients with generalized m=
yasthenia gravis in Japan
------------------------------------------------------------
=C2=B7 Japanese Ministry of Health, Labour and Welfare (MHLW) approves two =
UCB treatments, RYSTIGGO^=C2=AE (rozanolixizumab) and ZILBRYSQ^=C2=AE (zilu=
coplan), for the treatment of generalized myasthenia gravis (gMG) in adult =
patients (only for patients who inadequately respond to steroids or other i=
mmunosuppressants).^1,2=C2=A0
=C2=B7 Approvals are based on pivotal phase 3 data for both medicines, show=
ing statistical and clinically relevant improvements in gMG-specific outcom=
es^3,4=C2=A0
=C2=B7 Zilucoplan is the first once-daily subcutaneous, targeted C5 complem=
ent inhibitor for gMG. It is the only gMG-targeted therapy to be self-admin=
istered by adult patients=C2=A0
=C2=B7 Rozanolixizumab is a humanized IgG4 monoclonal antibody that binds t=
o the neonatal Fc receptor (FcRn), indicated for the treatment of adult pat=
ients with gMG
=C2=B7 With zilucoplan and rozanolixizumab, the Japanese gMG community is f=
irst in the world to benefit from choice of two new targeted therapies from=
a single company
=C2=B7 UCB=E2=80=99s two different medicines for gMG, each with a distinct =
mechanism of action, offer a unique portfolio of treatments that embody our=
commitment to addressing the gMG community=E2=80=99s unmet needs=C2=A0
Brussels (Belgium), 25 September 2023, 1800: (CET)=C2=A0- UCB (Euronext Bru=
ssels: UCB), a global biopharmaceutical company, today announced that the J=
apanese Ministry of Health, Labour and Welfare (MHLW) has granted approval =
for RYSTIGGO^=C2=AE (rozanolixizumab)^1 and for ZILBRYSQ^=C2=AE (zilucoplan=
)^2, for the treatment of generalized myasthenia gravis (gMG) in adult pati=
ents (only for patients who inadequately respond to steroids or other immun=
osuppressants).
Japan is the first country in the world to approve both rozanolixizumab and=
zilucoplan simultaneously. This means Japanese physicians and their patien=
ts will be the first to have choice of two new targeted therapies to treat =
gMG from one company, delivering unique optionality and versatility.=C2=A0
Combined with UCB=E2=80=99s highly regarded team of Japanese medical and sc=
ientific experts, and the company=E2=80=99s long-established heritage in ne=
urology, UCB has an opportunity to deliver individualized and transformatio=
nal patient value for adult patients in Japan living with gMG.
=E2=80=9CWith the approval in Japan of zilucoplan and rozanolixizumab, we a=
re very proud and excited to expand our support to the gMG community and to=
offer new and additional choices allowing treatment to be tailored accordi=
ng to patient needs.=E2=80=99 said Iris Loew-Friedrich, Executive Vice-Pres=
ident and Chief Medical Officer at UCB. =E2=80=9CI am confident that UCB wi=
ll be the only company able to deliver a portfolio of two targeted therapie=
s with different mechanisms of action and the experience to provide truly i=
ndividualized transformational patient value in managing this often-debilit=
ating rare disease, both at home and in the healthcare setting.=E2=80=9D=C2=
=A0
Today=E2=80=99s announcement marks the first approval worldwide of zilucopl=
an, the first once-daily subcutaneous (SC), targeted peptide inhibitor of c=
omplement component 5 (C5 inhibitor) and the only gMG target therapy for se=
lf-administration by adult patients with AChR antibody-positive gMG.^4 =C2=
=A0In September 2023, the Committee for Medicinal Products for Human Use (C=
HMP) of the European Medicines Agency (EMA) issued a positive opinion recom=
mending granting marketing authorization for zilucoplan in the European Uni=
on (EU) as an add-on to standard therapy for the treatment of generalized m=
yasthenia gravis (gMG) in adult patients who are anti acetylcholine recepto=
r (AChR) antibody positive.^5 A final decision on approval in the EU is exp=
ected before the end of the year, in line with the EMA=E2=80=99s standard r=
eview timeline.=C2=A0
As a C5 inhibitor, zilucoplan inhibits complement-mediated damage to the ne=
uromuscular junction through its targeted dual mechanism of action.4 Benefi=
ts of SC self-injection can include reduced traveling time to and from hosp=
itals, decreased interference with work obligations, and increased independ=
ence. Unlike monoclonal antibody C5 inhibitors, as a peptide, zilucoplan ca=
n be used concomitantly with intravenous immunoglobulin and plasma exchange=
, without the need for supplemental dosing.4
The Japanese MHLW approval of rozanolixizumab, for treatment of adults with=
generalized Myasthenia Gravis (only for patients who inadequately respond =
to steroids or other immunosuppressants)^1 is the second approval worldwide=
for this medicine, following approval by the U.S. Food and Drug Administra=
tion (FDA) in June 2023 for the treatment of gMG in adult patients who are =
anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase =
(MuSK) antibody positive.^6 Rozanolixizumab injection by subcutaneous infus=
ion is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc r=
eceptor (FcRn), resulting in the reduction of circulating IgG.^7=C2=A0
"With the approval of these two new medicines, we are very happy to take an=
additional step forward in contributing to gMG community - a new area for =
UCB in Japan=E2=80=9D, explained Kanako Kikuchi, Head of Neurology and Coun=
try Operations, UCB Japan. =E2=80=9CDeveloping and providing solutions for =
rare diseases, for which treatment options are often limited, is a very imp=
ortant commitment for our UCB team in Japan. Zilucoplan and rozanolixizumab=
are an important addition to our portfolio. By providing these two medicin=
es, each with their own mechanism of action, =C2=A0and way of administratio=
n, we are excited to support patients and physicians as they strive to mana=
ge the symptoms of gMG and to improve quality of life.=E2=80=9D
Zilucoplan: Supporting data
Approval of zilucoplan in Japan for the treatment of generalized myasthenia=
gravis (gMG) in adult patients (only for patients who inadequately respond=
to steroids or other immunosuppressants) is supported by safety and effica=
cy data from the Phase 3 RAISE study (NCT04115293), published in The Lancet=
Neurology in May 2023.^4=C2=A0
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.^4 MG-=
ADL is a measurement tool that assesses the impact of gMG on daily function=
s of 8 signs or symptoms that are typically affected in gMG. These include =
activities such as breathing, talking, swallowing, and being able to rise f=
rom a chair.^3 Each item is assessed on a 4-point scale where a score of 0 =
represents normal function and a score of 3 represents loss of ability to p=
erform that function. A total score ranges from 0 to 24, with the higher sc=
ores indicating more impairment.
A statistically significant and clinically meaningful difference favoring z=
ilucoplan in comparison to placebo was observed in the MG-ADL total score c=
hange from baseline: least squares mean change =E2=88=924.39 [95% CI =E2=80=
=935.28 to =E2=80=933.50] vs =E2=88=922.30 [=E2=80=933.17 to =E2=80=931.43]=
, least squares mean difference =E2=88=922.09 [=E2=88=923.24 to =E2=88=920.=
95]; p=3D0.0004. Secondary endpoints included change from baseline to Week =
12 in QMG, MGC and MG-QoL15r*.^4=C2=A0
A statistically significant and clinically meaningful difference favoring z=
ilucoplan compared to placebo was observed in the QMG total score change fr=
om baseline to Week 12 (p<0.0001), least squares mean change =E2=88=926.19 =
[95% CI =E2=88=927.29 to =E2=88=925.08] vs =E2=88=923.25 [=E2=88=924.32 to =
=E2=88=922.17].4=C2=A0
Change from baseline to Week 12 in MGC in comparison to placebo was clinica=
lly meaningful and statistically significant. MG-QoL 15r change from baseli=
ne to Week 12 compared to placebo was also statistically significant*.4=C2=
=A0
Additionally, improvements in fatigue were observed as an exploratory endpo=
int. Change from baseline to week 12 in the Neuro-QoL short-form fatigue sc=
ale was an exploratory end point, therefore, p value was nominal, not multi=
plicity controlled.^4
The most common adverse events (reported in at least 10% of patients treate=
d with zilucoplan within the RAISE study) were injection-site bruising, hea=
dache, diarrhea and MG worsening.^4
*The threshold for clinical meaningfulness for MG-QoL 15r has not been esta=
blished.
Rozanolixizumab: Supporting data
Approval of rozanolixizumab in Japan for the treatment of generalized myast=
henia gravis (gMG) in adult patients (only for patients who inadequately re=
spond to steroids or other immunosuppressants) is supported by safety and e=
fficacy data from the pivotal Phase 3 MycarinG study (NCT03971422), also pu=
blished in The Lancet Neurology in May 2023.^3=C2=A0
The primary efficacy endpoint was the comparison of the change from baselin=
e between treatment groups in the MG-ADL total score at Day 43.^3=C2=A0
Reductions in MG-ADL score from baseline to day 43 were greater in the roza=
nolixizumab 7 mg/kg group (least-squares mean change =E2=80=933.37 [SE 0=C2=
=B749]) and in the rozanolixizumab 10 mg/kg group (=E2=80=933.40 [0.49]) th=
an with placebo (=E2=80=930.78 [0.49]; for 7 mg/kg, least-squares mean diff=
erence =E2=88=922.59 [95% CI =E2=88=924.09 to =E2=88=921.25], p<0.0001; for=
10 mg/kg, =E2=88=922.62 [=E2=88=923.99 to =E2=88=921.16], p<0.0001).^3
Secondary efficacy endpoints included change from baseline to day 43 in the=
QMG. The QMG is a 13-item categorical grading system that assesses muscle =
weakness. Each item is assessed on a 4-point scale where a score of 0 repre=
sents no weakness and a score of 3 represents severe weakness. A total poss=
ible score ranges from 0 to 39, where higher scores indicate more severe im=
pairment. A statistically significant difference favoring rozanolixizumab c=
ompared to placebo was observed in the QMG total score change from baseline=
to day 43 [least squares mean difference -3.48 (95% CI (=E2=88=925.61 to =
=E2=88=921.58), p<0.0001 for rozanolixizumab 7mg/kg; least-squares mean dif=
ference =E2=88=924.76 (95% CI =E2=88=926.82 to =E2=88=922.86), p<0.0001 for=
rozanolixizumab 10mg/kg.^3
The most common adverse reactions (reported in at least 10% of patients tre=
ated with rozanolixizumab within the MycarinG study) were headache, infecti=
ons, diarrhea, pyrexia, hypersensitivity reactions, and nausea.^3=C2=A0
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.^9,10
In gMG, pathogenic autoantibodies can impair synaptic transmission at the n=
euromuscular junction (NMJ) by targeting specific proteins on the post-syna=
ptic membrane.^11 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.^9,10
About the MycarinG study3
The MycarinG study (NCT03971422) was a multi-center, Phase 3, randomized, d=
ouble-blind, placebo-controlled study evaluating the efficacy and safety of=
rozanolixizumab in adult patients with gMG, with an ongoing open-label ext=
ension.
The primary endpoint for the MycarinG study was change in the Myasthenia Gr=
avis-Activities of Daily Living (MG-ADL) score at day 43, an eight-item pat=
ient-reported scale developed to assess MG symptoms and their effects on da=
ily activities. Additional endpoints include changes in the Myasthenia Grav=
is composite (MGC) score, the Quantitative MG (QMG) score, patient-reported=
outcomes at Day 43 and adverse events (AEs).=C2=A0
The majority of patients taking part in the MycarinG study opted to enroll =
in any future extensions to this clinical trial. As a result, UCB is explor=
ing 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 the RAISE study^4
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.
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.=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).^4=C2=A0
For more information about the trial visit https://clinicaltrials.gov/ct2/s=
how/NCT04115293.=C2=A0
About rozanolixizumab
Rozanolixizumab is a subcutaneous administered, humanized monoclonal antibo=
dy that specifically binds, with high affinity, to human neonatal Fc recept=
or (FcRn). It has been designed to block the interaction of FcRn and Immuno=
globulin G (IgG), accelerating the catabolism of antibodies and reducing th=
e concentration of pathogenic IgG autoantibodies.^7
Rozanolixizumab-noli** was approved by the FDA in June, for the treatment o=
f gMG in adult patients who are anti-acetylcholine receptor (AChR) or anti-=
muscle-specific tyrosine kinase (MuSK) antibody positive,^12 having been gr=
anted Priority Review for its Biologic License Application (BLA). Rozanolix=
izumab is also under review by the European Medicines Agency (EMA), the Aus=
tralian Therapeutic Goods Administration (TGA) and Health Canada for the tr=
eatment of adults with gMG. Responses from regulatory agencies to these sub=
missions are expected during H2 2023 and H1 2024.=C2=A0
***In the U.S., the International Nonproprietary Name (INN) for rozanolixiz=
umab is =E2=80=98rozanolixizumab-noli=E2=80=99 following the FDA=E2=80=99s =
=E2=80=98Non-proprietary Naming of Biological Products Guidance=E2=80=99. T=
his guidance advises that the nonproprietary name designated for originator=
biological products should be a proper name that is a combination of the c=
ore name and a distinguishing suffix that is devoid of meaning and composed=
of four lowercase letters. This nomenclature only applies in the U.S.
About zilucoplan
Zilucoplan is a once-daily SC, self-administered peptide inhibitor of compl=
ement component 5 (C5 inhibitor). As a C5 inhibitor, zilucoplan inhibits co=
mplement-mediated damage to the neuromuscular junction through its targeted=
dual mechanism of action.^4=C2=A0
In September 2023, the Committee for Medicinal Products for Human Use (CHMP=
) of the European Medicines Agency (EMA) issued a positive opinion recommen=
ding granting marketing authorization for zilucoplan in the European Union =
(EU) as an add-on to standard therapy for the treatment of generalized myas=
thenia gravis (gMG) in adult patients who are anti acetylcholine receptor (=
AChR) antibody positive.^5 Zilucoplan is also currently under review by the=
U.S. FDA, the Australian Therapeutic Goods Administration (TGA) and Health=
Canada 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
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
UCB Rare Disease Communications (Japan)
T +81.03.6864.7650
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 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=
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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=
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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=
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es in tax laws or the administration of such laws, and hiring and retention=
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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=
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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=
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pacted by international and domestic trends toward managed care and health =
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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=
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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=
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UCB is following the worldwide developments diligently to assess the financ=
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to update any information contained in this press release, either to confir=
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Additionally, information contained in this document shall not constitute a=
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References:
1. Data on file: Japan MHLW, 25 September 2023
2. Data on file: Japan MHLW, 25 September 2023
3. Bril V et al. Efficacy and safety of rozanolixizumab in patients with ge=
neralised myasthenia gravis: a randomised, double-blind, placebo-controlled=
, adaptive Phase 3 study MycarinG study. Lancet Neurol. 2023;22(5):383-94.
4. 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
5. CHMP Positive Opinion: Zilbrysq https://www.ema.europa.eu/en/medicines/h=
uman/summaries-opinion/zilbrysq. date accessed September 2023
6. RYSTIGGO^=C2=AE U.S. Prescribing Information: https://www.ucb-usa.com/RY=
STIGGO-prescribing-information.pdf. date accessed September 2023
7. Smith B, et al. Generation and characterization of a high affinity anti-=
human FcRn antibody, rozanolixizumab, and the effects of different molecula=
r formats on the reduction of plasma IgG concentration. MAbs. 2018;10:1111-=
30.
8. Punga AR, et al. Epidemiology, diagnostics, and biomarkers of autoimmune=
neuromuscular junction disorders. Lancet Neurol. 2022;21(2):176-88.
9. National Institute of Neurological Disorders and Stroke. 2022. Myastheni=
a Gravis Fact Sheet. https://www.ninds.nih.gov/myasthenia-gravis-fact-sheet=
. Accessed August 2023.
10. Myasthenia Gravis Foundation of America. MG Quick Facts. https://myasth=
enia.org/MG-Education/MG-Quick-Facts (https://myasthenia.org/MG-Education/M=
G-Quick-Facts.) . Accessed September 2023=C2=A0
11. Juel VC, Massey JM. Myasthenia gravis. Orphanet J Rare Dis. 2007;2:44.
12. US Food and Drug Administration. Novel Drug approvals for 2023. https:/=
/www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-thera=
peutic-biological-products/novel-drug-approvals-2023. Accessed September 20=
23
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