https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r=
CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC=
rjYrJUHPDVbu1NKaBE-3DQQkG_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2=
FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN=
n-2B6FohpNoV33rPGQBEWyWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6irEZvZRs-2=
FZ4Laff9bM-2BNFy2c1s9Es-2B9tLpGKJMHiGf2VX9btJLfjnY72mEZeo5nVxkD8cas7Upy4JxO=
TycAOVrPQvqvU3QT97S4SdTxVuqhA93AapwlXJVEgYRi-2FhjUFJ1mndpmHtjVHIzpfVcdwwmBL=
v5V-2FWeebHpTcIpXo01eRgtipYuRrfIdT2M-3D
** FINTEPLA^=C2=AE=E2=96=BC (fenfluramine) oral solution approved in Japan =
for adjunctive treatment of seizures associated with Lennox-Gastaut syndrom=
e (LGS)
------------------------------------------------------------
Brussels, Belgium =E2=80=93 17 April 2024 =E2=80=93 7:00 AM CET=E2=80=93 UC=
B=E2=80=99s FINTEPLA^=C2=AE=E2=96=BC (fenfluramine) oral solution has been =
approved by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for=
the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as=
an add-on therapy to other anti-epileptic medicines for patients two years=
of age and older.^1=C2=A0
The approval by the MHLW was based on safety and efficacy data from a globa=
l, double-blind, placebo-controlled, parallel-group randomized Phase 3 clin=
ical trial (1601 Study Cohort A & B), in 296 patients with LGS (aged 2-35 y=
ears), including 33 in Japan. In the Japanese sub-population, adjunctive fe=
nfluramine, at a dose of 0.7 mg/kg/day, provided a greater reduction in the=
frequency of drop seizures compared to placebo. The most common (=E2=89=A5=
10%) non-cardiovascular treatment=E2=80=93emergent adverse events (TEAEs) w=
ere decreased appetite, somnolence, weight decreased, diarrhea, and nasopha=
ryngitis. No cases of valvular heart disease or pulmonary arterial hyperten=
sion were observed.^2
=E2=80=9CWe know that the unmet needs in Lennox-Gastaut syndrome are great,=
and we look forward to bringing this important treatment advancement to pe=
ople and families impacted by this condition in Japan. We are working to en=
sure that all patients who need our treatments can access them, and this ap=
proval further demonstrates that commitment,=E2=80=9D said Mike Davis, Head=
of Global Epilepsy & Rare Syndromes, UCB.=C2=A0
=E2=80=9CThis approval is an important milestone for UCB, delivering on our=
mission to bring several innovative new medicines to people living with se=
vere neurological and immunological diseases in Japan this year, =E2=80=9Cs=
aid Kanako Kikuchi, Head of UCB Japan. =E2=80=9CWe would like to thank our =
Japanese patients and families for participating in the clinical trials, en=
abling families and people impacted by Lennox-Gastaut to have this new trea=
tment option.=E2=80=9D
Lennox-Gastaut syndrome (LGS) is a childhood-onset severe developmental and=
epileptic encephalopathy (DEE), characterized by multiple types of drug-re=
sistant seizures, and associated with high morbidity and profound effects o=
n the quality of life (QoL) of patients and their families.^3,4 Motor, cogn=
itive, and behavioural abnormalities are lifelong, with serious intellectua=
l disability worsening over time.^5-9 Seizures leading to falls ("drop atta=
cks/seizures") are common in LGS and tonic seizures are a hallmark feature =
of this syndrome.^3,4 Among the typical seizures associated with a drop, th=
e generalized tonic=E2=80=93clonic seizures (GTCS) are commonly observed an=
d usually occur in later stages of LGS but sometimes may precede core seizu=
re types. In addition to being associated with bodily injury and hospitaliz=
ations, GTC seizures are a primary risk factor of sudden unexpected death i=
n epilepsy (SUDEP). Patients with epilepsy with GTC seizures have an approx=
imately 10-fold greater risk for SUDEP than patients with other seizure typ=
es.^2
Fenfluramine is marketed in Japan by Nippon Shinyaku Co., Ltd. based on the=
exclusive sales agreement signed in 2019 between Zogenix Inc., (acquired b=
y UCB in 2022) and Nippon Shinyaku Co., Ltd. UCB is the Marketing Authoriza=
tion holder.
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 approximately 9,000 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Fol=
low us on Twitter: @UCB_news
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
Global Communications
Nick Francis
T +44 7769 307745
email nick.francis@ucb.com =C2=A0
Important Safety Information about FINTEPLA=E2=96=BC (fenfluramine) in the =
EU^10
Active Ingredient: Oral solution: 2.2 mg fenfluramine (as fenfluramine hydr=
ochloride) per ml.=C2=A0
Indications: Treatment of seizures associated with Dravet syndrome and Lenn=
ox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines =
for patients 2 years of age and older.=C2=A0
Dosage and Administration: Please refer to SmPC for full information. Shoul=
d be initiated and supervised by physicians with experience in the treatmen=
t of epilepsy. Fintepla is prescribed and dispensed according to the Fintep=
la controlled access programme. Dravet syndrome: Patients who are not takin=
g stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). Afte=
r 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/=
kg/day). After an additional 7 days, if tolerated and further seizure reduc=
tion required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.=
7 mg/kg/day), which is the recommended maintenance dose. Patients requiring=
more rapid titration may increase the dose every 4 days. Do not exceed max=
imum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiri=
pentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 day=
s, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day)=
, which is the recommended maintenance dose. Patients requiring more rapid =
titration may increase the dose every 4 days. Do not exceed a total dose of=
17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 =
mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increas=
ed to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated. After an additio=
nal 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice dail=
y (0.7 mg/kg/day), which is the recommended maintenance dose. Do not exceed=
maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When dis=
continuing treatment, decrease the dose gradually. As with all anti-epilept=
ic medicines, avoid abrupt discontinuation when possible to minimize the ri=
sk of increased seizure frequency and status epilepticus. A final echocardi=
ogram should be conducted 3-6 months after the last dose of treatment with =
fenfluramine. Renal impairment: Generally, no dose adjustment is recommende=
d when administered to patients with mild to severe renal impairment, howev=
er, a slower titration may be considered. If adverse reactions are reported=
, a dose reduction may be needed. Has not been studied in patients with end=
-stage renal disease. Not known if fenfluramine or its active metabolite, n=
orfenfluramine, is dialyzable. Hepatic impairment: Hepatic impairment: Gene=
rally, no dose adjustment is recommended when Fintepla is administered with=
out concomitant stiripentol to patients with mild and moderate hepatic impa=
irment (Child-Pugh Class A and B). In patients with severe hepatic impairme=
nt (Child-Pugh C) not receiving concomitant stiripentol, the maximum dosage=
is 0.2mg/kg twice daily, and the maximal total daily dose is 17 mg. There =
are limited clinical data on the use of Fintepla with stiripentol in patien=
ts with mild impaired hepatic function. A slower titration may be considere=
d in patients with hepatic impairment and a dose reduction may be needed if=
adverse reactions are reported. No clinical data is available on the use o=
f Fintepla with stiripentol in moderate and severe hepatic impairment, ther=
efore not recommended for use. Elderly: No data available. Paediatric popul=
ation: Safety and efficacy in children below 2 years of age not yet establi=
shed. No data available.=C2=A0
Contraindications: Hypersensitivity to active substance or any excipients. =
Aortic or mitral valvular heart disease and pulmonary arterial hypertension=
. Within 14 days of the administration of monoamine oxidase inhibitors due =
to an increased risk of serotonin syndrome.=C2=A0
Warnings and Precautions: Aortic or mitral valvular heart disease and pulmo=
nary arterial hypertension: Prior to starting treatment, patients must unde=
rgo an echocardiogram to establish a baseline and exclude any pre-existing =
valvular heart disease or pulmonary hypertension. Conduct echocardiogram mo=
nitoring every 6 months for the first 2 years and annually thereafter. If a=
n echocardiogram indicates pathological valvular changes, consider follow-u=
p earlier to evaluate whether the abnormality is persistent. If pathologica=
l abnormalities seen on echocardiogram, evaluate the benefit versus risk of=
continuing fenfluramine treatment with the prescriber, caregiver and cardi=
ologist. Once treatment is discontinued for any reasons, a final echocardio=
gram should be conducted 3-6 months after the last dose of treatment with f=
enfluramine. If echocardiogram findings suggestive of pulmonary arterial hy=
pertension, perform a repeat echocardiogram as soon as possible and within =
3 months to confirm these findings. If echocardiogram finding is confirmed =
suggestive of an increased probability of pulmonary arterial hypertension d=
efined as intermediate probability, conduct a benefit-risk evaluation of co=
ntinuation of Fintepla by the prescriber, carer and cardiologist. If echoca=
rdiogram suggests a high probability, it is recommended fenfluramine treatm=
ent should be stopped. Decreased appetite and weight loss: Fenfluramine can=
cause decreased appetite and weight loss - an additive effect can occur in=
combination with other anti-epileptic medicines such as stiripentol. Monit=
or the patient=E2=80=99s weight. Undertake risk-benefit evaluation before s=
tarting treatment if history of anorexia nervosa or bulimia nervosa. Fintep=
la controlled access programme: A controlled access programme has been crea=
ted to 1) prevent off-label use in weight management in obese patients and =
2) confirm that prescribing physicians have been informed of the need for p=
eriodic cardiac monitoring in patients taking Fintepla. Somnolence: Fenflur=
amine can cause somnolence which could be potentiated by other central nerv=
ous system depressants. Suicidal behaviour and ideation: Suicidal behaviour=
and ideation have been reported in patients treated with anti-epileptic me=
dicines in several indications. Advise patients and caregivers to seek medi=
cal advice should any signs of suicidal behaviour and ideation emerge. Sero=
tonin syndrome: Serotonin syndrome, a potentially life-threatening conditio=
n, may occur with fenfluramine treatment, particularly with concomitant use=
of other serotonergic agents; with agents that impair metabolism of seroto=
nin such as MAOIs; or with antipsychotics that may affect the serotonergic =
neurotransmitter systems. Carefully observe the patient, particularly durin=
g treatment initiation and dose increases. Increased seizure frequency: A c=
linically relevant increase in seizure frequency may occur during treatment=
, which may require adjustment in the dose of fenfluramine and/or concomita=
nt anti-epileptic medicines, or discontinuation of fenfluramine, should the=
benefit-risk be negative. Cyproheptadine: Cyproheptadine is a potent serot=
onin receptor antagonist and may therefore decrease the efficacy of fenflur=
amine. If cyproheptadine is added to treatment with fenfluramine, monitor p=
atient for worsening of seizures. If fenfluramine treatment is initiated in=
a patient taking cyproheptadine, fenfluramine=E2=80=99s efficacy may be re=
duced. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle=
closure glaucoma. Discontinue therapy in patients with acute decreases in =
visual acuity. Consider discontinuation if ocular pain of unknown origin. E=
ffect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 in=
ducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations,=
which may lower the efficacy of fenfluramine. If co-administration is cons=
idered necessary, the patient should be monitored for reduced efficacy and =
a dose increase of fenfluramine could be considered provided that it does n=
ot exceed twice the maximum daily dose (52 mg/day). If a strong CYP1A2 or C=
YP2B6 inducer is discontinued during maintenance treatment with fenfluramin=
e, consider gradual reduction of the fenfluramine dosage to the dose admini=
stered prior to initiating the inducer. Effect of CYP1A2 or CYP2D6 inhibito=
rs: Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhi=
bitor may result in higher exposure and, therefore, adverse events should b=
e monitored, and a dose reduction may be needed in some patients. Excipient=
s: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl par=
a-hydroxybenzoate (E 219) - may cause allergic reactions (possibly delayed)=
. It also contains sulfur dioxide (E 220) which may rarely cause severe hyp=
ersensitivity reactions and bronchospasm. Patients with rare glucose-galact=
ose malabsorption should not take this medicine. The product contains less =
than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially=
=E2=80=98sodium-free=E2=80=99. Contains glucose - may be harmful to teeth.=
Interactions: Pharmacodynamic interactions with other CNS depressants incr=
ease the risk of aggravated central nervous system depression. An increase =
in dose may be necessary when coadministered with rifampicin or a strong CY=
P1A2 or CYP2B6 inducer. In in vitro studies co-administration with a strong=
CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 =
of the SmPC). Co-administration with CYP2D6 substrates or MATE1 substrates =
may increase their plasma concentrations. Co-administration with CYP2B6 or =
CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and l=
actation: Limited data in pregnant women. As a precaution, avoid use of Fin=
tepla in pregnancy. It is unknown whether fenfluramine/metabolites are excr=
eted in human milk. Animal data have shown excretion of fenfluramine/metabo=
lites in milk. A decision must be made whether to discontinue breast-feedin=
g or to discontinue/abstain from Fintepla taking into account the benefit o=
f breast-feeding for the child and the benefit of therapy for the woman. Dr=
ive and use machines.: Fintepla has moderate influence on the ability to dr=
ive/ use machines as it may cause somnolence and fatigue. Advise patients n=
ot to drive or operate machinery until they have sufficient experience to g=
auge whether it adversely affects their abilities.=C2=A0
Adverse effects: Dravet syndrome: Very common (=E2=89=A51/10): Upper respir=
atory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, =
fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of tra=
ce and mild mitral regurgitation, and trace aortic regurgitation, which are=
considered physiologic). Common (=E2=89=A51/100 to <1/10): Bronchitis, abn=
ormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypo=
tonia, lethargy, seizure, status epilepticus, tremor, constipation, salivar=
y hypersecretion, weight decreased and blood prolactin increased. Not known=
(cannot be estimated from the available data): Pulmonary arterial hyperten=
sion. Lennox-Gastaut syndrome: Very common (=E2=89=A51/10): Upper respirato=
ry tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fa=
tigue. Common (=E2=89=A51/100 to <1/10): Bronchitis, influenza, pneumonia, =
aggression, seizure, status epilepticus, lethargy, tremor, constipation, sa=
livary hypersecretion, blood prolactin increased, weight decreased, fall. R=
efer to SmPC for other adverse reactions. Pharmaceutical Precautions: Use w=
ithin 3 months of opening. Do not refrigerate or freeze. Package Quantities=
and Marketing Authorisation Number: Fintepla is presented in a white bottl=
e with oral syringes included which should be used to administer the prescr=
ibed dose. Bottle sizes of 60 mL, 120 mL, 250mL and 360 mL. EU/1/20/1491/00=
1, EU/1/20/1491/002, EU/1/20/1491/003 and EU/1/20/1491/004. Legal Category:=
POM. Marketing Authorisation Holder: UCB Pharma S.A. All=C3=A9e de la Rech=
erche 60, B-1070 Bruxelles, Belgium. Date of revision: 27 March 2024.
=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.
FINTEPLA^=C2=AE is a registered trademark of the UCB Group of Companies.
Refer to the European Summary of Product Characteristics for further safety=
information and full prescribing information.=C2=A0
https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r=
C2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQ=
aFCaKaA-2FhhHiEtjJrI6ETeeE-2B8v74OWhjYCGt58GnH1fk5gg70icujQcJqxcsLpcg-3D-3D=
pZbh_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TS=
az3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33rPGQBEW=
yWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6irEZvZRs-2FZ4Laff9bM-2BNFy2c1s9=
Es-2B9tLpGKDIXZq1RR8qgwwVdHqy-2FLS4KVDmbduH9OYAwtJYFRooZK33UHb7ocf6XtzoW5T-=
2FGpGAfAMekRV-2FKSf8xol3-2Buqn9bGf5wG-2FF5Wbhw1s0o-2FayQlL4qKU0OkaU-2FRkAf-=
2FZPDypLJSVFFKKlwdX0tHnTVrQ-3D
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: change=
s in general economic, business and competitive conditions, the inability t=
o obtain necessary regulatory approvals or to obtain them on acceptable ter=
ms or within expected timing, costs associated with research and developmen=
t, changes in the prospects for products in the pipeline or under developme=
nt by UCB, effects of future judicial decisions or governmental investigati=
ons, safety, quality, data integrity or manufacturing issues; potential or =
actual data security and data privacy breaches, or disruptions of our infor=
mation technology systems, product liability claims, challenges to patent p=
rotection for products or product candidates, competition from other produc=
ts including biosimilars, changes in laws or regulations, exchange rate flu=
ctuations, changes or uncertainties in tax laws or the administration of su=
ch laws, and hiring and retention of its employees. There is no guarantee t=
hat new product candidates will be discovered or identified in the pipeline=
, will progress to product approval or that new indications for existing pr=
oducts will be developed and approved. Movement from concept to commercial =
product is uncertain; preclinical results do not guarantee safety and effic=
acy of product candidates in humans. So far, the complexity of the human bo=
dy cannot be reproduced in computer models, cell culture systems or animal =
models. The length of the timing to complete clinical trials and to get reg=
ulatory approval for product marketing has varied in the past and UCB expec=
ts similar unpredictability going forward. Products or potential products, =
which are the subject of partnerships, joint ventures or licensing collabor=
ations may be subject to differences disputes between the partners or may p=
rove to be not as safe, effective or commercially successful as UCB may hav=
e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui=
re other products or companies and to integrate the operations of such acqu=
ired companies may not be as successful as UCB may have believed at the mom=
ent of acquisition. Also, UCB or others could discover safety, side effects=
or manufacturing problems with its products and/or devices after they are =
marketed. The discovery of significant problems with a product similar to o=
ne of UCB=E2=80=99s products that implicate an entire class of products may=
have a material adverse effect on sales of the entire class of affected pr=
oducts. Moreover, sales may be impacted by international and domestic trend=
s toward managed care and health care cost containment, including pricing p=
ressure, political and public scrutiny, customer and prescriber patterns or=
practices, and the reimbursement policies imposed by third-party payers as=
well as legislation affecting biopharmaceutical pricing and reimbursement =
activities and outcomes. Finally, a breakdown, cyberattack or information s=
ecurity breach could compromise the confidentiality, integrity and availabi=
lity of UCB=E2=80=99s data and systems.=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=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.=C2=A0
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release. UCB expressly disclaims any duty t=
o update any information contained in this press release, either to confirm=
the actual results or to report or reflect any change in its forward-looki=
ng statements with regard thereto or any change in events, conditions or ci=
rcumstances on which any such statement is based, unless such statement is =
required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
n offer to sell or the solicitation of an offer to buy any securities, nor =
shall there be any offer, solicitation or sale of securities in any jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction.
References:
1. MHLW Notice 26 March 2024. https://u7061146.ct.sendgrid.net/ls/click?upn=
=3Du001.gqh-2BaxUzlo7XKIuSly0rCyy0FBvi5xRQ58W-2BfSbWbcPb0nIRcgL2snYlfCmI8hQ=
-2F9t-2Fco6Nw9VlS8vwQlN9E6jEVr0T1I49Yd-2B32jIoy3EQ-3Dd27W_2dCLUNbuBjhX746-2=
FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3=
MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33rPGQBEWyWjOUwNPK4Z82f-2BDB6SH=
MwgWrKtDq4JCWyUopircJ6irEZvZRs-2FZ4Laff9bM-2BNFy2c1s9Es-2B9tLpGKDmqRDDK9pdw=
mSpjtXkYWeg-2B87m2nyqI-2B5rOdcB7L4C8atN-2Bc-2BXRmc-2BrUJ9gdQaXwcuU7hbQLGW7j=
kkcuiCWbE6vSKK2dWg-2FuWSrNwjubrlJj2PfNA5qGhZiOzmCm4p2arMQtYH-2FWT5PXADmrErm=
rO0-3D Accessed March 2024.
2. Knupp K, Scheffer I, Ceulemans B, et al. Efficacy and safety of fenflura=
mine for the treatment of seizures associated with Lennox-Gastaut syndrome.=
A Randomized Clinical Trial. JAMA Neurol. 2022;79(6):554-564
3. Strzelczyk A, Schubert-Bast S. Expanding the Treatment Landscape for Len=
nox-Gastaut Syndrome: Current and Future Strategies. CNS Drugs. 2021;35(1):=
61-83.
4. Specchio, N, Wirrell, EC, Scheffer, IE, Nabbout, R, Riney, K, Samia, P, =
et al. International League Against Epilepsy classification and definition =
of epilepsy syndromes with onset in childhood: Position paper by the ILAE T=
ask Force on Nosology and Definitions. Epilepsia. 2022;63:1398-1442.
5. Reaven NL, Funk SE, Montouris GD, et al. Burden of illness in patients w=
ith possible Lennox-Gastaut syndrome: a retrospective claims-based study. E=
pilepsy Behav.2018;88:66-73.
6. Reyhani A, =C3=96zkara =C3=87. The unchanging face of Lennox-Gastaut syn=
drome in adulthood. Epilepsy Res. 2021;172:106575.
7. Auvin S, Damera V, Martin M, et al. The impact of seizure frequency on q=
uality of life in patients with Lennox-Gastaut syndrome or Dravet syndrome.=
Epilepsy Behav. 2021;123:108239.
8. Jahngir MU, Ahmad MQ, Jahangir M. Lennox-Gastaut syndrome: in a nutshell=
. Cureus. 2018;10(8):e3134.
9. Mastrangelo M. Lennox-Gastaut syndrome: a state of the art review. Neuro=
pediatrics. 2017;48(3):143-51.
10. Fintepla^=C2=AE EU SmPC. https://u7061146.ct.sendgrid.net/ls/click?upn=
=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-=
2FtfvSeD3KLQsazq58-2BxwfyV7LSQaFCaKaA-2FhhHiEtjJrI6ETeeE-2B8v74OWhjYCGt58Gn=
H1T27RJn16IWmxyZWsDIvi2A-3D-3DVdRL_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPG=
CjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33S=
bkEZvEGLNn-2B6FohpNoV33rPGQBEWyWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6i=
rEZvZRs-2FZ4Laff9bM-2BNFy2c1s9Es-2B9tLpGKBLBavSKvLloRO3S8nWEoeIReFTtw8hshua=
YZiFWkw5VO8vY-2BSKMNEwK5-2FRuCFx9ld3Y8m1BbA7Fk2O-2BRFxz2hbFfOW-2FAUrMbwYOqK=
HbcyZBgrqTM3Pwq-2FfWtxX6s5X50XTp-2FhV-2BiWS0w8asWLRoLWk-3D Accessed March 2=
023.
GenericFile
UCB PR Fintepla for LGS Japan Approval April 17 2024 ENG (https://u7061146.=
ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyBv9bezcPT-2BuIt=
TLKIHepafsoeIB9L1yKMHYtFqrtje6-2FBCAWm9uxnsx7S6a3s3RjMH3soqsT3trU6vN75-2B3P=
E-3Do7hT_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2I=
J0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33rPG=
QBEWyWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6irEZvZRs-2FZ4Laff9bM-2BNFy2=
c1s9Es-2B9tLpGKFepRVpouMeL3CmcxW0TeRktI3WFIt8gKYBafZ42zKzvJzWbqdHzAdeCztW0S=
hPaFeUQFfwT07f9RjVErw8R1CvVSVKN1qTSN3QYJiYGa-2FA-2Beswk93jsbta4obrZQp2PoiI-=
2BlhIEUo9-2Bjv7wSeD6sus-3D
______________________
If you would rather not receive future communications from UCB SA, please g=
o to https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIu=
Sly0rC3nfmD42E6tJ6HwHGmqtXbhtXDlQ2cTEdRpWV-2BrYPIUN7QgPG-2FBTQhHgNVyPWqHaa8=
p3tkzxjTeHB0c4i6dSWqzzKXU9z-2BiFlU6SvRpS27N85yQmJJ7oOeEI1B5cx29HlEQjLC3ll2X=
l9M5qwZCfKek-3DAB9K_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2=
nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6F=
ohpNoV33rPGQBEWyWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6irEZvZRs-2FZ4Laf=
f9bM-2BNFy2c1s9Es-2B9tLpGKGCjF2SmkgTP2ccrGGipIQWgdI1MnJrAk-2FIUD34k6HP7F1l1=
YI6gLrLDPGwf1ed4bUdEuegVYErBVyJTUCEDjK3IV158kYdhQ1U6TljZrY3Wy2UbVG-2BgozZOV=
lVKaMXmcSxlsTGRoi9uIocZjDyUgAY-3D
UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium
