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** UCB presents new data at 35th International Epilepsy Congress (IEC) high=
lighting important advancements across Fintepla^=C2=AE=E2=96=BC(fenfluramin=
e) oral solution and broader epilepsies portfolio
------------------------------------------------------------
=C2=B7 9 abstracts showcase new data for fenfluramine^1 in rare epilepsies =
(including late-breaking data on safety profile and efficacy of fenfluramin=
e in adults living with Dravet syndrome) and brivaracetam^2 in the treatmen=
t of focal onset seizures of different aetiologies as well as when switchin=
g from other anti-seizure medications
=C2=B7 Data presented from the Seizure Termination Project =E2=80=93 an exp=
ert group developing recommendations on rapid and early seizure termination
=C2=B7 UCB will host two symposia: =E2=80=98Rapid Early Seizure Termination=
=E2=80=93 Time is brain and more=E2=80=99 (September 3, 18.00-19.30 CET), =
and =E2=80=98Making a difference together for patients with developmental a=
nd epileptic encephalopathies=E2=80=99 (September 4, 09.00-10.30 CET)
=C2=A0
Brussels, Belgium, 31 August 2023 =E2=80=93 07.00 AM CET =E2=80=93 Nine abs=
tracts, including one late-breaker and two oral presentations, will be pres=
ented at the 35th International Epilepsy Congress (IEC) taking place from S=
eptember 2-6, 2023. Presentations span multiple forms of epilepsy, as well =
as rare epileptic conditions such as Dravet syndrome (DS), Lennox-Gastaut s=
yndrome (LGS) and CDKL5 (cyclin-dependent kinase-like 5) deficiency disorde=
r.
Mike Davis, Head of Global Epilepsy & Rare Syndromes, UCB, said: =E2=80=9CU=
tilizing our experience and expertise, we continuously challenge the status=
quo in our drive to do more for people living with a variety of seizure ty=
pes and rare syndromes =E2=80=93 from innovative early research, to researc=
h in conditions where we have considerable history and heritage, as well as=
in new therapy areas where we are addressing important unmet needs in Drav=
et and Lennox-Gastaut syndrome =E2=80=93 our data at IEC really underlines =
where we are working to have a positive impact. Our ambition is to do more =
to improve the lives of patients and families now, and in the future.=E2=80=
=9D=C2=A0
Data to be presented at the 35th International Epilepsy Congress (IEC)
Fenfluramine impact in children and adults living with Dravet syndrome (DS)=
and Lennox-Gastaut syndrome (LGS)
A review of published studies where patients were treated with fenfluramine=
to manage convulsive seizures - including generalized tonic-clonic seizure=
s (GTCS) or tonic-clonic seizures (TCS) - was conducted to examine the effi=
cacy of fenfluramine on GTCS reduction in various types of Developmental an=
d Epileptic Encephalopathies (DEEs) or rare epilepsy conditions. Data from =
13 studies (4 randomized-controlled trials (RCTs), 4 observational studies,=
4 open-label studies, and 1 case series) were included in the review.^3
In total 561 patients were included in the review (including 360 patients w=
ith Dravet syndrome and 176 with Lennox-Gastaut syndrome). Not all patients=
in these studies experienced GTCS or TCS. Eight studies (N=3D117) reported=
the proportion of patients experiencing =E2=89=A575% and/or 100% reduction=
in GTCS or TCS; 70% and 55% of patients reported =E2=89=A575% and 100% red=
uction in GTCS or TCS, respectively. 5 studies reported more than half of p=
atients were GTCS-free after fenfluramine treatment.^3
Lead author and Professor Helen Cross, the Prince of Wales's Chair of Child=
hood Epilepsy & Director of UCL Great Ormond Street Institute of Child Heal=
th, London, and Young Epilepsy, Lingfield, UK commented: =E2=80=9CThese dat=
a demonstrated striking levels of GTCS control, setting new standards for w=
hat can be achieved in Dravet syndrome, but also providing important insigh=
ts into treatment for other developmental and epileptic encephalopathies. T=
hese seizures are one of our main concerns because of the risk of SUDEP (Su=
dden Unexpected Death in Epilepsy).=E2=80=9D
Orrin Devinsky, MD, Director of NYU Langone Health=E2=80=99s Comprehensive =
Epilepsy Center, US, said: =E2=80=9CThe impact of Dravet and Lennox-Gastaut=
syndromes are far reaching, with many emotional and practical consequences=
for parents, siblings, relatives and loved ones. These data are raising th=
e bar in what can be achieved in advancing the care for both children and a=
dults living with these difficult to treat conditions.=E2=80=9D
Late-breaking data presented at IEC also provide additional new evidence on=
the safety profile and efficacy of fenfluramine in adults living with Drav=
et syndrome.^4
In LGS, data include an evaluation of the impact of age and weight on the r=
eduction of seizures associated with a fall, in patients in the phase 3 ran=
domized clinical trial and open-label extension study (NCT03355209). These =
data suggest that fenfluramine treatment results in effective, sustained re=
ductions in frequency of seizures associated with a fall in adults with LGS=
, comparable to results in children and adolescents with LGS, and in patien=
ts with LGS weighing =E2=89=A537.5kg, comparable to results in patients wei=
ghing <37.5kg.^5
Focal-Onset Seizures
Data presented on brivaracetam will look at the effectiveness and tolerabil=
ity profile of this treatment in adults with epilepsy of different aetiolog=
y, including people with brain tumor-related epilepsy, post-stroke epilepsy=
, and traumatic brain injury-related epilepsy.^6 Additionally, data from th=
e EXPERIENCE analysis will assess effectiveness and tolerability profile of=
brivaracetam in patients switching from levetiracetam and patients switchi=
ng from other antiseizure medications.^7=C2=A0
Rapid and Early Seizure Termination
Expert consensus recommendations will also be presented from the Seizure Te=
rmination Project*, discussing best practice for rapid termination of seizu=
re episodes to prevent progression to a higher-level emergency. The advisor=
s unanimously agreed that an ideal acute seizure termination treatment woul=
d start to act within 2 minutes of administration to terminate ongoing seiz=
ure activity. Consensus was also reached on goals and potential benefits of=
rapid seizure termination and specific patient and seizure types that coul=
d benefit most from rapid termination.^8 The project aims to fill the gap w=
hich exists in guidelines for seizure emergencies.=C2=A0
Pipeline programs**
In CDKL5 deficiency disorder (CDD), a poster describes the design of an ong=
oing, two-part, multi-center trial of fenfluramine in people with CDD and u=
ncontrolled seizures, outlining how the study will characterize efficacy an=
d safety of the treatment.^9
Symposia=C2=A0
UCB-supported symposia aim to increase knowledge and awareness of the diffe=
rent seizure emergencies and the importance of rapid termination of certain=
ongoing seizures, and the impact of DEEs on seizure and non-seizure outcom=
es, with focus on adult patients:
1. Prolonged seizures - Time is brain and more: Sunday, 3rd September 18.00=
-19.30 CET, will differentiate the different seizure emergencies and descri=
be the clinical relevance and burden of prolonged seizure duration and prog=
ression to more severe seizure types.
2. Making a difference together for patients with developmental and epilept=
ic encephalopathies: Monday, 4th September 09:00-10.30 CET, will increase t=
he knowledge of DEEs with focus on the awareness of the impact of seizure a=
nd non-seizure outcomes along the patient lifetime, advancing collaboration=
between specialists in the transition of patients from pediatric to adult =
care and sharing best practice on complex clinical cases in DS and LGS.
UCB presentations during IEC 2023
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About FINTEPLA^=C2=AE=E2=96=BC(fenfluramine) oral solution in EU^1
Fintepla is indicated for the treatment of seizures associated with Dravet =
syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epi=
leptic medicines for patients 2 years of age and older. Fenfluramine is a s=
erotonin releasing agent, and thereby stimulates multiple 5-HT receptor sub=
-types through the release of serotonin. Fenfluramine may reduce seizures b=
y acting as an agonist at specific serotonin receptors in the brain, includ=
ing the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sig=
ma-1 receptor. The precise mode of action of fenfluramine in Dravet syndrom=
e and Lennox-Gastaut syndrome is not known.
Fenfluramine oral solution is available under a controlled access program t=
o ensure regular cardiac monitoring and to mitigate potential off-label use=
.
Refer to the European Summary of Product Characteristics (https://www.ema.e=
uropa.eu/en/documents/product-information/fintepla-epar-product-information=
_en.pdf) (SmPC) for other adverse reactions and full prescribing informatio=
n.=C2=A0
=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.
Important Safety Information about FINTEPLA^=E2=96=BC in EU
Aortic or mitral valvular heart disease and pulmonary arterial hypertension
Because of reported cases of valvular heart disease that may have been caus=
ed by fenfluramine at higher doses used to treat adult obesity, cardiac mon=
itoring must be performed using echocardiography. In the controlled clinica=
l studies of fenfluramine for the treatment of Dravet syndrome and Lennox-G=
astaut syndrome, no valvular heart disease was observed. Prior to starting =
treatment, patients must undergo an echocardiogram to establish a baseline =
prior to initiating treatment and exclude any pre-existing valvular heart d=
isease or pulmonary hypertension. Echocardiogram monitoring should be condu=
cted every 6 months for the first 2 years and annually thereafter. If an ec=
hocardiogram indicates pathological valvular changes, a follow-up echocardi=
ogram should be considered at an earlier timeframe to evaluate whether the =
abnormality is persistent. If pathological abnormalities on the echocardiog=
ram are observed, it is recommended to evaluate the benefit versus risk of =
continuing fenfluramine treatment with the prescriber, caregiver, and cardi=
ologist. If treatment is stopped because of aortic or mitral valvular heart=
disease, appropriate monitoring and follow-up should be provided in accord=
ance with local guidelines for the treatment of aortic or mitral valvular h=
eart disease. With past use in higher doses to treat adult obesity, fenflur=
amine was reported to be associated with pulmonary arterial hypertension. P=
ulmonary arterial hypertension was not observed in the clinical programme, =
but because of the low incidence of this disease, the clinical trial experi=
ence with fenfluramine is inadequate to determine if fenfluramine increases=
the risk for pulmonary arterial hypertension in patients with Dravet syndr=
ome and Lennox-Gastaut syndrome. If echocardiogram findings are suggestive =
of pulmonary arterial hypertension, a repeat echocardiogram should be perfo=
rmed as soon as possible and within 3 months to confirm these findings. If =
the echocardiogram finding is confirmed suggestive of an increased probabil=
ity of pulmonary arterial hypertension defined as =E2=80=9Cintermediate pro=
bability=E2=80=9D by the 2015 European Society of Cardiology (ESC) and the =
European Respiratory Society (ERS) Guidelines, it should lead to a benefit-=
risk evaluation of continuation of Fintepla by the prescriber, carer, and c=
ardiologist. If the echocardiogram finding, after confirmation, suggests of=
a high probability of pulmonary arterial hypertension, as defined by the 2=
015 ESC and ERS Guidelines, it is recommended fenfluramine treatment should=
be stopped.
Decreased appetite and weight loss=C2=A0
Fenfluramine can cause decreased appetite and weight loss. An additive effe=
ct on decreased appetite can occur when fenfluramine is combined with other=
anti-epileptic medicines, for example stiripentol. The decrease in weight =
appears to be dose related. Most subjects resumed weight gain over time whi=
le continuing treatment. The patient's weight should be monitored. A benefi=
t risk evaluation should be undertaken prior to commencing treatment with f=
enfluramine in patients with a history of anorexia nervosa or bulimia nervo=
sa.
Fintepla controlled access programme
A controlled access programme has been created to 1) prevent off-label use =
in weight management in obese patients and 2) confirm that prescribing phys=
icians have been informed of the need for periodic cardiac monitoring in pa=
tients taking Fintepla.=C2=A0
Somnolence
Fenfluramine can cause somnolence. Other central nervous system depressants=
, including alcohol, could potentiate the somnolence effect of fenfluramine=
.
Suicidal behaviour and ideation=C2=A0
Suicidal behaviour and ideation have been reported in patients treated with=
anti-epileptic medicines in several indications. A meta-analysis of random=
ised placebo-controlled trials with anti-epileptic medicines that did not i=
nclude fenfluramine has shown a small increased risk of suicidal behaviour =
and ideation. The mechanism of this risk is not known, and the available da=
ta do not exclude the possibility of an increased risk for fenfluramine. Pa=
tients and caregivers of patients should be advised to seek medical advice =
should any signs of suicidal behaviour and ideation emerge.
Serotonin syndrome
As with other serotonergic agents, serotonin syndrome, a potentially life-t=
hreatening condition, may occur with fenfluramine treatment, particularly w=
ith concomitant use of other serotonergic agents (including SSRIs, SNRIs, t=
ricyclic antidepressants, or triptans); with agents that impair metabolism =
of serotonin such as MAOIs; or with antipsychotics that may affect the sero=
tonergic neurotransmitter systems. Serotonin syndrome symptoms may include =
mental status changes (eg, agitation, hallucinations, coma), autonomic inst=
ability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscul=
ar aberrations (eg, hyperreflexia, incoordination), and/or gastrointestinal=
symptoms (eg, nausea, vomiting, diarrhoea). If concomitant treatment with =
fenfluramine and other serotonergic agents that may affect the serotonergic=
systems is clinically warranted, careful observation of the patient is adv=
ised, particularly during treatment initiation and dose increases.
Increased seizure frequency
As with other anti-epileptic medicines, a clinically relevant increase in s=
eizure frequency may occur during treatment with fenfluramine, which may re=
quire adjustment in the dose of fenfluramine and/or concomitant anti-epilep=
tic medicines, or discontinuation of fenfluramine, should the benefit-risk =
be negative.=C2=A0
Cyproheptadine=C2=A0
Cyproheptadine is a potent serotonin receptor antagonist and may therefore =
decrease the efficacy of fenfluramine. If cyproheptadine is added to treatm=
ent with fenfluramine, patients should be monitored for worsening of seizur=
es. If fenfluramine treatment is initiated in a patient taking cyproheptadi=
ne, fenfluramine=E2=80=99s efficacy may be reduced.
Glaucoma
Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma=
. Discontinue therapy in patients with acute decreases in visual acuity. Co=
nsider discontinuation if there is ocular pain and another cause cannot be =
determined.
Effect of CYP1A2 and CYP2B6 inducers
Co-administration with strong CYP1A2 inducers or CYP2B6 inducers will decre=
ase fenfluramine plasma concentrations, which may lower the efficacy of fen=
fluramine. If co-administration of a strong CYP1A2 or CYP2B6 inducer with f=
enfluramine is considered necessary, the patient should be monitored for re=
duced efficacy and a dose increase of fenfluramine could be considered prov=
ided that it does not exceed twice the maximum daily dose (52 mg/day). If a=
strong CYP1A2 or CYP2B6 inducer is discontinued during maintenance treatme=
nt with fenfluramine, consider gradual reduction of the fenfluramine dosage=
to the dose administered prior to initiating the inducer.
Effect of CYP1A2 or CYP2D6 inhibitors
Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhibito=
r may result in higher exposure and, therefore, adverse events should be mo=
nitored, and a dose reduction may be needed in some patients.
Coadministration of a single 0.35 mg/kg dose of fenfluramine with fluvoxami=
ne (a strong CYP1A2 inhibitor) at steady state (50 mg once daily) in health=
y volunteers increased the AUC0-t of fenfluramine by a ratio of 2.1-fold an=
d the Cmax by a ratio of 1.2-fold, and decreased the AUC0-t of norfenfluram=
ine by a ratio of 1.3-fold and the Cmax by a ratio of 1.4-fold, as compared=
to fenfluramine administered alone.=C2=A0
Coadministration of a single 0.35 mg/kg dose of fenfluramine with paroxetin=
e (a strong CYP2D6 inhibitor) at steady state (30 mg once daily) in healthy=
volunteers increased the AUC0-t of fenfluramine by a ratio of 1.8-fold and=
the Cmax by a ratio of 1.1-fold, and decreased the AUC0-t of norfenflurami=
ne by a ratio of 1.2-fold and the Cmax by a ratio of 1.3-fold, as compared =
to fenfluramine administered alone.
Excipients
This medicinal product contains sodium ethyl para-hydroxybenzoate (E 215) a=
nd sodium methyl para hydroxybenzoate (E 219) which may cause allergic reac=
tions (possibly delayed). It also contains sulfur dioxide (E 220) which may=
rarely cause severe hypersensitivity reactions and bronchospasm. Patients =
with rare glucose-galactose malabsorption should not take this medicinal pr=
oduct. This medicinal product contains less than 1 mmol sodium (23 mg) per =
the maximum daily dose of 12 mL, that is to say essentially =E2=80=98sodium=
-free=E2=80=99. This medicinal product contains glucose which may be harmfu=
l to the teeth.
About BRIVIACT^=C2=AE (brivaracetam) in the EU^2
BRIVIACT (brivaracetam) is indicated as adjunctive therapy in the treatment=
of partial-onset seizures with or without secondary generalisation in adul=
ts, adolescents and children from 2 years of age with epilepsy.=C2=A0
Refer to the European Summary of Product Characteristics (https://www.ema.e=
uropa.eu/en/documents/product-information/briviact-epar-product-information=
_en.pdf) for other adverse reactions and full prescribing information.=C2=
=A0
Important Safety Information about BRIVIACT in the EU=C2=A0
Contraindications=C2=A0
Hypersensitivity to the active substance, other pyrrolidone derivatives or =
any of the excipients.=C2=A0
Special warnings and precautions for use
Suicidal ideation and behaviour have been reported in patients treated with=
anti-epileptic drugs (AEDs) in several indications, including BRIVIACT. =
=C2=A0Patients should be monitored for signs of suicidal ideation and behav=
iour and appropriate treatment should be considered. Patients (and caregive=
rs) should be advised to seek medical advice should any signs of suicidal i=
deation or behaviour emerge. BRIVIACT film-coated tablets contain lactose. =
Patients with rare hereditary problems of galactose intolerance, total lact=
ase deficiency or glucose-galactose malabsorption should not take BRIVIACT.=
Brivaracetam film-coated tablets, solution for injection/infusion and oral=
solution contain less than 1 mmol sodium (23mg) per tablet/vial/ml respect=
ively, that is to say essentially =E2=80=98sodium free=E2=80=99. The oral s=
olution contains 168 mg sorbitol (E420) in each ml. Patients with hereditar=
y fructose intolerance (HFI) should not take this medicinal product. The or=
al solution contains methyl parahydroxybenzoate (E218), which may cause all=
ergic reactions (possibly delayed). Brivaracetam oral solution contains pro=
pylene glycol (E1520).=C2=A0
Posology
No dose adjustment is needed in adults with impaired renal function. Based =
on data in adults, no dose adjustment is necessary neither in paediatric pa=
tients with impaired renal function. No clinical data are available in paed=
iatric patients with renal impairment. In patients with hepatic impairment,=
the following adjusted doses, administered in 2 divided doses, approximate=
ly 12 hours apart, are recommended for all stages of hepatic impairment: In=
adults, adolescents and children weighing =E2=89=A550 kg, a 50 mg/day star=
ting dose is recommended, with a maximum daily dose of 150 mg/day. For adol=
escents and children weighing from 20 kg to <50 kg, a 1 mg/kg/day starting =
dose is recommended, with a maximum daily dose of 3 mg/kg/day. For children=
weighing from 10 kg to <20 kg, a 1 mg/kg/day starting dose is recommended,=
with a maximum daily dose of 4 mg/kg/day. No clinical data are available i=
n paediatric patients with hepatic impairment.=C2=A0
Interaction with other medicinal products and other forms of interaction
With co-administration of BRIVIACT 200 mg single dose and ethanol 0.6 g/L c=
ontinuous infusion in healthy subjects there was no pharmacokinetic interac=
tion, but the effect of alcohol on psychomotor function, attention and memo=
ry was doubled. Intake of BRIVIACT with alcohol is not recommended. Limited=
clinical data are available implying that coadministration of cannabidiol =
may increase the plasma exposure of brivaracetam, possibly through CYP2C19 =
inhibition, but the clinical relevance is uncertain. In healthy subjects, c=
o-administration with rifampicin, a strong enzyme-inducer (600 mg/day for 5=
days), decreased BRIVIACT area under the plasma concentration curve (AUC) =
by 45%. Prescribers should consider adjusting the dose of BRIVIACT for pati=
ents starting or ending treatment with rifampicin. Other strong enzyme-indu=
cers (such as St John=C2=B4s wort [Hypericum perforatum]) may also decrease=
the systemic exposure of BRIVIACT. Therefore, starting or ending treatment=
with St John=E2=80=99s wort should be done with caution. In vitro studies =
have shown that brivaracetam exhibits little or no inhibition of CYP450 iso=
forms except for CYP2C19. Brivaracetam may increase plasma concentrations o=
f medicinal products metabolised by CYP2C19 (e.g., lansoprazole, omeprazole=
, diazepam). CYP2B6 induction has not been investigated in vivo and BRIVIAC=
T may decrease plasma concentrations of medicinal products metabolised by C=
YP2B6 (e.g. efavirenz). In vitro studies have also shown that BRIVIACT has =
inhibitory effects on OAT3. BRIVIACT 200 mg/day may increase plasma concent=
rations of medicinal products transported by OAT3. BRIVIACT plasma concentr=
ations are decreased when co-administered with strong enzyme inducing antie=
pileptic drugs (carbamazepine, phenobarbital, phenytoin) but no dose adjust=
ment is required.=C2=A0
Effects on ability to drive and use machines=C2=A0
BRIVIACT, has minor or moderate influence on the ability to drive and use m=
achines. Patients should be advised not to drive a car or to operate other =
potentially hazardous machines until they are familiar with the effects of =
BRIVIACT, on their ability to perform such activities.=C2=A0
Undesirable effects
The most frequently reported adverse reactions with BRIVIACT (reported by >=
10% of patients) were somnolence (14.3%) and dizziness (11.0%). They were u=
sually mild to moderate in intensity. Somnolence and fatigue were reported =
at higher incidences with increasing dose. Very common adverse reactions (=
=E2=89=A51% to <10%) were influenza, decreased appetite, depression, anxiet=
y, insomnia, irritability, convulsion, vertigo, upper respiratory tract inf=
ections, cough, nausea, vomiting, constipation and fatigue. Neutropenia has=
been reported in 0.5% (6/1,099) BRIVIACT patients and 0% (0/459) placebo-t=
reated patients. Four of these patients had decreased neutrophil counts at =
baseline, and experienced additional decrease in neutrophil counts after in=
itiation of BRIVIACT. None of the six cases were severe, required any speci=
fic treatment, led to BRIVIACT discontinuation, or had associated infection=
s. Suicidal ideation was reported in 0.3 % (3/1099) of BRIVIACT treated pat=
ients and 0.7 % (3/459) of placebo-treated patients. In short-term clinical=
studies of BRIVIACT in patients with epilepsy, there were no cases of comp=
leted suicide and suicide attempt, however both were reported in the long-t=
erm open-label extension studies. Reactions suggestive of immediate (Type I=
) hypersensitivity have been reported in a small number of BRIVIACT patient=
s (9/3022) during clinical development. The safety profile of brivaracetam =
observed in children from 1 month of age was consistent with the safety pro=
file observed in adults. In the open label, uncontrolled, long-term studies=
suicidal ideation was reported in 4.7 % of paediatric patients assessed fr=
om 6 years onwards (more common in adolescents) compared with 2.4 % of adul=
ts and behavioural disorders were reported in 24.8 % of paediatric patients=
compared with 15.1 % of adults. The majority of events were mild or modera=
te in intensity, were non-serious, and did not lead to discontinuation of s=
tudy drug. An additional adverse reaction reported in children was psychomo=
tor hyperactivity (4.7 %). No specific pattern of adverse event (AE) was id=
entified in children from 1 month to < 4 years of age when compared to olde=
r paediatric age groups. No significant safety information was identified i=
ndicating the increasing incidence of a particular AE in this age group. As=
data available in children younger than 2 years of age are limited, brivar=
acetam is not indicated in this age range. No clinical data are available i=
n neonates.=C2=A0
Overdose
There is limited clinical experience with BRIVIACT overdose in humans. Somn=
olence and dizziness were reported in a healthy subject taking a single dos=
e of 1,400 mg of BRIVIACT. The following adverse reactions were reported wi=
th brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatig=
ue, irritability, aggression, insomnia, depression, and suicidal ideation i=
n the post-marketing experience. In general, the adverse reactions associat=
ed with brivaracetam overdose were consistent with the known adverse reacti=
ons. There is no specific antidote. Treatment of an overdose should include=
general supportive measures. Since less than 10% of BRIVIACT is excreted i=
n urine, haemodialysis is not expected to significantly enhance BRIVIACT cl=
earance.
BRIVIACT^=C2=AE and FINTEPLA^=C2=AE are registered trademarks of the UCB Gr=
oup of Companies.
For further information, contact UCB:=C2=A0
Global Communications
Nick Francis
T +44 7769 307745
email nick.francis@ucb.com =C2=A0
Corporate Communications
Laurent Schots
T +32.2.559.92.64
email laurent.schots@ucb.com
Investor Relations
Antje Witte
T +32.2.559.94.14
email 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. 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 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. Given these uncertainties, you should not place undue reliance on an=
y of such forward-looking statements. There can be no guarantee that the in=
vestigational or approved products described in this press release will be =
submitted or approved for sale or for any additional indications or labelli=
ng in any market, or at any particular time, nor can there be any guarantee=
that such products will be or will continue to be commercially successful =
in the future. UCB is providing this information, including forward-looking=
statements, only as of the date of this press release and it does not refl=
ect any potential impact from the evolving COVID-19 pandemic, unless indica=
ted otherwise. UCB is following the worldwide developments diligently to as=
sess the financial significance of this pandemic to UCB. UCB expressly disc=
laims any duty to update any information contained in this press release, e=
ither to confirm the actual results or to report or reflect any change in i=
ts forward-looking statements with regard thereto or any change in events, =
conditions or circumstances on which any such statement is based, unless su=
ch statement is required pursuant to applicable laws and regulations. Addit=
ionally, information contained in this document shall not constitute an off=
er 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 jurisdiction=
in which such offer, solicitation or sale would be unlawful prior to the r=
egistration or qualification under the securities laws of such jurisdiction=
.
References:
1. Fintepla^=C2=AE EU SmPC. https://www.ema.europa.eu/en/documents/product-=
information/fintepla-epar-product-information_en.pdf (Accessed August 2023)=
.
2. Briviact^=C2=AE EU SmPC. https://www.ema.europa.eu/en/documents/product-=
information/briviact-epar-product-information_en.pdf (Accessed August 2023)=
.
3. Cross H, Devinsky O, Gil-Nagel A. Effect of Fenfluramine on Generalized =
Tonic-Clonic Seizures in Rare Epilepsy Syndromes: A Review of Published Stu=
dies. Poster presented at: International Epilepsy Congress (IEC); 2023, Sep=
tember 2-6; Dublin, Ireland.
4. Sanchez-Carpintero R, Devinsky O, Gil-Nagel A. Safety and Efficacy of Fe=
nfluramine in Adult Patients with Dravet Syndrome Enrolled De Novo in an Op=
en-Label Extension Study. Poster presented at: International Epilepsy Congr=
ess (IEC); 2023, September 2-6; Dublin, Ireland.
5. Scheffer IE, Ceulemans B, Sullivan J, et al. Impact of Fenfluramine on D=
rop Seizure Frequency in Adults or Dose-Capped Patients With Lennox-Gastaut=
Syndrome: Comparative Analysis of Clinical Trial Data. Poster presented at=
: International Epilepsy Congress (IEC); 2023, September 2-6; Dublin, Irela=
nd.
6. Strzelczyk A, D=E2=80=99Souza W, Faught E, et al. 12-Month Effectiveness=
and Tolerability of Brivaracetam in Patients With Epilepsy Stratified by E=
tiology at Baseline in the Real-World: Subgroup Data From the International=
EXPERIENCE Pooled Analysis. Poster presented at: International Epilepsy Co=
ngress (IEC); 2023, September 2-6; Dublin, Ireland.
7. Steinhoff BJ, D=E2=80=99Souza W, Faught E, et al. 12-Month Effectiveness=
and Tolerability of Brivaracetam in Patients With Epilepsy Switching From =
Levetiracetam Vs Other Antiseizure Medications in the Real-World: Subgroup =
Data From the International EXPERIENCE Pooled Analysis. Poster presented at=
: International Epilepsy Congress (IEC); 2023, September 2-6; Dublin, Irela=
nd.
8. Pina Garza JE, Chez M, Cloyd J, et al. The Seizure Termination Project: =
Expert Consensus Recommendations for the Rapid Termination of Seizure Emerg=
encies. Poster presented at: International Epilepsy Congress (IEC); 2023, S=
eptember 2-6; Dublin, Ireland.
9. Devinsky O, Olsen HE, Rajaraman RR, et al. Design of a Phase 3 Clinical =
Study to Examine the Efficacy and Safety of Fenfluramine in Subjects With C=
DKL5 Deficiency Disorder Followed by an Open-Label Extension. Poster presen=
ted at: International Epilepsy Congress (IEC); 2023, September 2-6; Dublin,=
Ireland.
*The Seizure Termination Project was funded by UCB Pharma.
**The safety and efficacy of fenfluramine for the treatment of CDD has not =
been established and it is not currently approved for use in this indicatio=
n by any regulatory authority worldwide
=C2=A0
GenericFile
UCB PR IEC August 31 2023 ENG (https://mb.cision.com/Public/18595/3826229/b=
020e4d489bdda7e.pdf) Image
Chart 1 IEC 2023 (https://mb.cision.com/Public/18595/3826229/8be6ce526767c2=
52_org.png)
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