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UCB Media Room: Vimpat CHMP positive opinion in PGTCS

INFORMATION REGLEMENTEE


[22/10/2020 | 07:04]
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513=
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QyiCPWUVcuARTWTKtNyhSGwExSumAqbbf8YJvie0UcJhw-2Bc-3D

** UCB=E2=80=99s anti-epileptic drug VIMPAT^=C2=AE (lacosamide) receives EU=
CHMP positive opinion for primary generalised tonic-clonic seizures
------------------------------------------------------------

=C2=B7 Committee for Medicinal Products for Human Use (CHMP) of the Europea=
n Medicines Agency (EMA) has adopted a positive opinion on a licence extens=
ion for its anti-epileptic drugs VIMPAT (lacosamide) and Lacosamide UCB (la=
cosamide) as adjunctive therapy in the treatment of primary generalised ton=
ic-clonic seizures in adults, adolescents and children from 4 years of age =
with idiopathic generalised epilepsy^1=C2=A0(IGE)
=C2=B7 IGEs (idiopathic generalised epilepsy) account for 20%=E2=80=9340% o=
f all epilepsies^2, characterized by different generalized seizure types (a=
bsence, myoclonic and PGTCS)^3=C2=A0
=C2=B7 Patients living with generalized tonic-clonic seizures have an incre=
ased risk of injury^4 and those who experienced three or more in one year h=
ad a fifteen-fold increased risk of sudden unexpected death in epilepsy^5
=C2=B7 UCB awaits decision from the European Commission (EC) on the potenti=
al approval of this new VIMPAT^=C2=AE =C2=A0license extension in the Europe=
an Union=C2=A0

Brussels (Belgium), 22 October 2020, 07:00 (CEST): UCB today announced that=
the Committee for Medicinal Products for Human Use (CHMP) of the European =
Medicines Agency (EMA) has adopted a positive opinion on a licence extensio=
n for its anti-epileptic drugs VIMPAT^=C2=AE (lacosamide) and Lacosamide UC=
B (lacosamide) as adjunctive therapy in the treatment of primary generalise=
d tonic-clonic seizures in adults, adolescents and children from 4 years of=
age with idiopathic generalised epilepsy.

The positive opinion is based, in part, on results from a phase 3 study of =
lacosamide as adjunctive treatment for uncontrolled primary generalized ton=
ic-clonic seizures (PGTCS), recently published in the Journal of Neurology,=
Neurosurgery & Psychiatry.^6=C2=A0

In the study, UCB=E2=80=99s anti-epileptic Drug (AED) lowered the risk of d=
eveloping a second primary generalized tonic-clonic seizure during a 24-wee=
k period and demonstrated a significantly higher rate of freedom from PGTCS=
during the treatment period compared with placebo. Lacosamide was generall=
y tolerated by patients enrolled in the study.=C2=A0

Idiopathic generalized epilepsy, (IGEs) account for 20%=E2=80=9340% of all =
epilepsies^2 and are characterized by different generalized seizure types (=
absence, myoclonic and PGTCS).^3 Patients living with generalized tonic-clo=
nic seizures have an increased risk of injury^4 and those who experienced t=
hree or more in one year had a fifteen-fold increased risk of sudden unexpe=
cted death in epilepsy.^5

=E2=80=9CPeople living with uncontrolled primary generalized tonic-clonic s=
eizures face tremendous challenges and currently have few treatment options=
available to them. This form of epilepsy can be devastating, significantly=
impacting the quality of a patient=E2=80=99s life. Additionally, many pati=
ents are refractory, meaning they do not respond to currently approved medi=
cines. This unpredictability can present numerous challenges and barriers=
=E2=80=9D, explained Iris Loew-Friedrich, Executive Vice President and Chie=
f Medical Officer, UCB. =E2=80=9CWe are very pleased the CHMP has recognise=
d the impact of PGTCS, and the importance of broadening the number of adjun=
ctive therapies available to people living with this type of epilepsy=E2=80=
=9D.

The European Commission=E2=80=99s (EC) formal approval decision is expected=
before the end of 2020, which would further broaden the clinical applicati=
on of VIMPAT^=C2=AE and make a new treatment option available to aid the ma=
nagement of PGTCS.=C2=A0
=C2=A0
=E2=80=9CUCB remains committed to strengthening our leadership in epilepsy =
and to investigating new approaches and innovative solutions to deliver imp=
roved outcomes and experiences to the global epilepsy community. This appli=
es equally to our current expansive in-market epilepsy portfolio as well as=
to our exciting pipeline. We know that people living with PGTCS currently =
have limited treatment options. With today=E2=80=99s CHMP positive opinion =
we=E2=80=99re excited that we=E2=80=99re one step closer to having an appro=
ved medicine to support the European epilepsy community,=E2=80=9D explained=
Charl van Zyl, Executive Vice President & Head of Neurology Solutions, UCB.

VIMPAT^=C2=AE is currently not approved for PGTCS in any country in the wor=
ld. In addition to this CHMP positive opinion, regulatory reviews for use o=
f VIMPAT as adjunctive therapy in the treatment of primary generalized toni=
c-clonic seizures in patients with idiopathic generalized epilepsy four yea=
rs of age and older compared to placebo are underway in the U.S., Japan, an=
d Australia.

About Epilepsy
Epilepsy is the main symptom of a variety of chronic disorders of the brain=
. It is the fourth most common neurological condition worldwide and affects=
approximately 65 million people.^7 Anyone can develop epilepsy; it occurs =
across all ages, races and genders, and is defined as one or more unprovoke=
d epileptic seizures with a risk of further seizures.^8

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 30 years of experience in the=
research and development of anti-epileptic drugs. As a company with a long=
-term commitment to epilepsy research, our goal is to address unmet medical=
needs. Our scientists are proud to contribute to advances in the understan=
ding of epilepsy and its treatment. We partner and create super-networks wi=
th world-leading scientists and clinicians in academic institutions, pharma=
ceutical companies, and other organizations who share our goals. At UCB, we=
are inspired by patients, and driven by science in our commitment to suppo=
rt patients with epilepsy.

About UCB
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, the company generated revenue of =E2=82=AC 4.9=
billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news=C2=A0

About VIMPAT^=C2=AE =C2=A0in the EU=C2=A0
VIMPAT^=C2=AE was first launched in the European Union in September 2008, a=
s adjunctive therapy for the treatment of partial-onset seizures with or wi=
thout secondary generalization in adult and adolescent (16-18 years) patien=
ts with epilepsy.=C2=A0

In countries of the EU, VIMPAT^=C2=AE is available as film-coated tablets, =
syrup and solution for infusion. Lacosamide solution for infusion is an alt=
ernative for patients when oral administration is temporarily not feasible.=
=C2=A0=C2=A0

Important Safety Information about VIMPAT^=C2=AE in the EU and EEA^9 =C2=A0
VIMPAT^=C2=AE is indicated as monotherapy and adjunctive therapy in the tre=
atment of partial-onset seizures with or without secondary generalisation i=
n adults, adolescents and children from 4 years of age with epilepsy. VIMPA=
T^=C2=AE therapy can be initiated with either oral or IV administration. Fo=
r the paediatric population, the physician should prescribe the most approp=
riate formulation and strength according to weight and dose. A single loadi=
ng dose may be initiated in patients in situations when the physician deter=
mines that rapid attainment of lacosamide steady state plasma concentration=
and therapeutic effect is warranted. It should be administered under medic=
al supervision with consideration of the potential for increased incidence =
of serious cardiac arrhythmia and CNS adverse reactions. Administration of =
a loading dose has not been studied in acute conditions such as status epil=
epticus. Use of a loading dose is not recommended in adolescents and childr=
en weighing less than 50 kg. Administration of a loading dose has not been =
studied in children. A maximum dose of 300 mg/day is recommended for paedia=
tric patients with mild to moderate hepatic impairment weighing 50 kg or mo=
re and for adult patients with mild to moderate hepatic impairment as well.=
=C2=A0Based on data in adults, in paediatric patients weighing less than 5=
0 kg with mild to moderate hepatic impairment, a reduction of 25 % of the m=
aximum dose should be applied. Lacosamide should be administered to adult a=
nd paediatric patients with severe hepatic impairment only when the expecte=
d therapeutic benefits are anticipated to outweigh the possible risks. The =
dose may need to be adjusted while carefully observing disease activity and=
potential side effects in the patient. In adolescents and adults weighing =
50 kg or more with mild to moderate hepatic impairment a loading dose of 20=
0mg may be considered, but further dose titration (>200 mg daily) should be=
performed with caution. In paediatric patients weighing 50 kg or more and =
in adult patients with mild or moderate renal impairment a loading dose of =
200 mg may be considered, but further dose titration (> 200 mg daily) shoul=
d be performed with caution. In paediatric patients weighing 50 kg or more =
and in adult patients with severe renal impairment (CLCR =E2=89=A4 30 ml/mi=
n) or with end-stage renal disease, a maximum dose of 250 mg/day is recomme=
nded and the dose titration should be performed with caution. In paediatric=
patients weighing less than 50 kg with severe renal impairment (CLCR =E2=
=89=A4 30 ml/min) and in those with end-stage renal disease, a reduction of=
25 % of the maximum dose is recommended. Contraindications: Hypersensitivi=
ty to the active substance or any of the excipients; known second- or third=
-degree atrioventricular (AV) block. Special warnings and precautions for u=
se: Treatment with VIMPAT^=C2=AE has been associated with dizziness which c=
ould increase the occurrence of accidental injury or falls. Therefore, pati=
ents should be advised to exercise caution until they are familiar with the=
potential effects of the medicine. Dose-related prolongations in PR interv=
al with VIMPAT=C2=AE have been observed in clinical studies. =C2=A0VIMPAT^=
=C2=AE should be used with caution in patients with underlying proarrhythmi=
c conditions such as patients with known cardiac conduction problems or sev=
ere cardiac disease (e.g. myocardial ischaemia/infarction, heart failure, s=
tructural heart disease or cardiac sodium channelopathies) or patients trea=
ted with medicinal products affecting cardiac conduction, including antiarr=
hythmics and sodium channel blocking antiepileptic medicinal products, as w=
ell as in elderly patients. In these patients it should be considered to pe=
rform an ECG before a Vimpat dose increase above 400mg/day and after Vimpat=
is titrated to steady-state. In the placebo-controlled trials of VIMPAT^=
=C2=AE in epilepsy patients, atrial fibrillation or flutter were not report=
ed; however both have been reported in open-label epilepsy trials and in po=
st-marketing experience. In post-marketing experience, AV block (including =
second degree or higher AV block) has been reported. In patients with proar=
rhythmic conditions, ventricular tachyarrhythmia has been reported. In rare=
cases, these events have led to asystole, cardiac arrest and death in pati=
ents with underlying proarrhythmic conditions. Patients should be made awar=
e of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular puls=
e, palpitations, shortness of breath, feeling lightheaded, fainting). Patie=
nts should be counselled to seek immediate medical advice if these symptoms=
occur. Suicidal ideation and behaviour have been reported in patients trea=
ted with antiepileptic medicinal products in several indications. Therefore=
patients should be monitored for signs of suicidal ideation and behaviours=
and appropriate treatment should be considered. Patients (and caregivers o=
f patients) should be advised to seek medical advice should signs of suicid=
al ideation or behaviour emerge. The safety and efficacy of lacosamide in p=
aediatric patients with epilepsy syndromes in which focal and generalised s=
eizures may coexist have not been determined. VIMPAT^=C2=AE syrup contains =
sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions=
(possibly delayed). Vimpat Syrup contains sorbitol (E420). Patients with r=
are hereditary problems of fructose intolerance should not take this medici=
ne. Sorbitol may cause gastrointestinal discomfort and mild laxative effect=
.The syrup contains aspartame (E951), a source of phenylalanine, which may =
be harmful for people with phenylketonuria. Vimpat syrup contains propylene=
glycol (E1520). VIMPAT=C2=AE syrup contains 1.42 mg sodium per ml, equival=
ent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for=
an adult. VIMPAT^=C2=AE solution for infusion contains 59.8 mg sodium per =
vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g s=
odium for an adult. Effects on ability to drive and use machines: VIMPAT^=
=C2=AE may have minor to moderate influence on the ability to drive and use=
machines. VIMPAT^=C2=AE treatment has been associated with dizziness or bl=
urred vision. Accordingly patients should be advised not to drive a car or =
to operate other potentially hazardous machinery until they are familiar wi=
th the effects of VIMPAT^=C2=AE on their ability to perform such activities=
. Undesirable effects: The most common adverse reactions (=E2=89=A510%) are=
dizziness, headache, diplopia, and nausea. They were usually mild to moder=
ate in intensity. Some were dose-related and could be alleviated by reducin=
g the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse=
reactions usually decreased over time. Incidence of CNS adverse reactions =
such as dizziness may be higher after a loading dose. Other common adverse =
reactions (=E2=89=A51% - <10%) are depression, confusional state, insomnia,=
balance disorder, memory impairment, cognitive disorder, somnolence, tremo=
r, nystagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthe=
sia, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence,=
dyspepsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait distu=
rbance, asthenia, fatigue, irritability, feeling drunk, injection site pain=
or discomfort (local adverse events associated with intravenous administra=
tion), irritation (local adverse events associated with intravenous adminis=
tration), fall, and skin laceration, contusion. The use of VIMPAT^=C2=AE is=
associated with dose-related increase in the PR interval. Adverse reaction=
s associated with PR interval prolongation (e.g. atrioventricular block, sy=
ncope, bradycardia) may occur. The safety profile of lacosamide in placebo-=
controlled and in open-label studies (n=3D408) in adjunctive therapy in chi=
ldren from 4 years of age was consistent with the safety profile observed i=
n adults although the frequency of some adverse reactions (somnolence, vomi=
ting and convulsion) was increased and additional adverse reactions (nasoph=
aryngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal =
behaviour) have been reported in paediatric patients: nasopharyngitis (15.7=
%), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (1=
3.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %)=
, lethargy (2.7 %) and abnormal behaviour (1.7 %).=C2=A0
Laboratory abnormalities: Abnormalities in liver function tests have been o=
bserved in placebo-controlled trials with VIMPAT^=C2=AE in adult patients w=
ith partial-onset seizures who were taking 1-3 concomitant antiepileptic me=
dicinal products. Elevations of ALT to =E2=89=A53xULN occurred in 0.7% (7/9=
35) of VIMPAT^=C2=AE patients and 0% (0/356) of placebo patients. Multiorga=
n Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also k=
nown as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have =
been reported in patients treated with some antiepileptic medicinal product=
s. These reactions are variable in expression but typically present with fe=
ver and rash and can be associated with involvement of different organ syst=
ems. If multiorgan hypersensitivity reaction is suspected, VIMPAT^=C2=AE sh=
ould be discontinued.=C2=A0

Refer to the European Summary of Product Characteristics for other adverse =
reactions and full prescribing information.

Date of revision: 03 Sept 2019. https://u7061146.ct.sendgrid.net/ls/click?u=
pn=3DTeZUXWpUv-2B6TCY38pVLo9jARV652O70bxLkiVOQ6QQFaz823LgXYQfOLYLIfWCIFPtNl=
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FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1waMUPJ5UdWwbHN5nzBZQCL8K9ebk-2FJpcFW0i=
YDoFhbpuyY-2F04S-2Fng2SfT5GChXYRgfQFqpeJEt-2FK-2Ff6-2FuhPYmIfueT4-2F4WDwPs7=
BXnT8qwpwmP4LbmtQpZx-2BWwxLE2qo35nPMe0smVfrbF0oOkLdG9L545pLOQdUUszhMVpwCFQt=
cNbtVuR3lOMEWIzt0DQquEIIjEu4mEWypemfvAIHimEcIsEjYPsiIfHHUr9zH3tYwkPfWoi9ZM-=
2B0dSdl74tmAQ-3D

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October

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