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** U.S. FDA Approves FINTEPLA^=C2=AE =E2=96=BC(fenfluramine) Oral Solution =
for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS)
------------------------------------------------------------
=C2=B7 Approval based on data where fenfluramine demonstrated efficacy in t=
he most difficult to treat seizure types,1,2 including drop seizures, which=
cause a person to suddenly lose muscle tone, become limp, and fall to the =
ground with a high likelihood of injury^3
=C2=B7 LGS is a severe childhood-onset developmental and epileptic encephal=
opathy characterized by drug-resistant seizures with high morbidity^4 as we=
ll as serious impairment of neurodevelopmental, cognitive, and motor functi=
ons.^5 LGS affects an estimated 30,000 =E2=80=93 50,000 patients in the U.S=
.^6
=C2=B7 Approval highlights UCB=E2=80=99s commitment to bringing differentia=
ted medicines to specific epilepsy patient populations where there is a hig=
h unmet need
Brussels (Belgium), and Atlanta, Ga. (USA) 28 March 2022 =E2=80=93 7 a.m. C=
ET =E2=80=93 UCB (Euronext: UCB), a global biopharmaceutical company, today=
announced that FINTEPLA^=C2=AE (fenfluramine) oral solution CIV has been a=
pproved in the United States, by the U.S. Food and Drug Administration (FDA=
) for the treatment of seizures associated with Lennox-Gastaut syndrome in =
patients two years of age and older.^1 Additionally, the FDA has granted pe=
diatric exclusivity for the product.^7=C2=A0It is already approved for the =
treatment of seizures associated with Dravet syndrome in patients two years=
of age and older in the US and EU.^1,8=C2=A0Fenfluramine for LGS is availa=
ble in the US through a restricted distribution program, called the Risk Ev=
aluation and Mitigation Strategy (REMS) Program.=C2=A0
LGS is a severe childhood-onset developmental and epileptic encephalopathy =
(DEE) characterized by drug-refractory seizures with high morbidity^4 as we=
ll as serious impairment of neurodevelopmental, cognitive, and motor functi=
ons.^5 LGS affects an estimated 30,000 =E2=80=93 50,000 patients in the U.S=
.^6 LGS has far-reaching effects beyond seizures, including issues with com=
munication, psychiatric symptoms, sleep, behavioral challenges, and mobilit=
y.^9=C2=A0Additionally, sudden unexpected death in epilepsy (SUDEP) is a ma=
jor concern for people living with LGS.^10
Fenfluramine has demonstrated efficacy in the most difficult to treat seizu=
re types,^1,2 including drop seizures, which cause a person to suddenly los=
e muscle tone, become limp, and fall to the ground with a high likelihood o=
f injury.^3 Fenfluramine has a mechanism of action different from and compl=
ementary to current seizure medications, and it can be used with no disrupt=
ions to current antiseizure regimens.^11=C2=A0In the global placebo-control=
led phase 3 clinical trial, there were numerically greater improvements on =
the Clinical Global Impression scale (CG-I) in patients living with LGS whe=
n taking fenfluramine.^1
=E2=80=9CThe approval of fenfluramine for Lennox-Gastaut syndrome highlight=
s our continued commitment to bringing differentiated medicines to patients=
who may not be well controlled on current therapies, and their caregivers,=
=E2=80=9D said Mike Davis, Head of Global Epilepsy, UCB. =E2=80=9CWe are pr=
oud to add fenfluramine as a treatment for Dravet syndrome, and now Lennox-=
Gastaut syndrome, to our portfolio of epilepsy medicines to help reduce the=
impact and burden of seizures, including severe epilepsy syndromes that ha=
ve high pediatric morbidity and mortality rates.=E2=80=9D
The FDA approval was supported by safety and efficacy data from a global, r=
andomized, placebo-controlled Phase 3 clinical trial in 263 patients with L=
GS (age 2-35 years), which demonstrated that fenfluramine at a dose of 0.7/=
mg/kg/day significantly reduced the frequency of drop seizures compared to =
placebo (p=3D0.0037). Nearly a fourth of those patients on fenfluramine 0.7=
mg/kg/day experienced a =E2=89=A550% reduction in drop seizure frequency p=
er 28 days; =C2=A018% with >50 to <75% reduction and 6% >75% reduction.^1 T=
he common adverse reactions that occurred in patients treated with fenflura=
mine (incidence at least 10% and greater than placebo) were diarrhea; decre=
ased appetite; fatigue; somnolence; vomiting.^1 The fenfluramine safety dat=
abase includes long-term cardiovascular safety data for patients treated fo=
r up to three years in DS and LGS.^1=C2=A0
=E2=80=9CLGS is one of the most challenging epileptic encephalopathies to t=
reat, and the vast majority of patients are not well controlled, despite a =
regimen of multiple antiepileptic drugs,=E2=80=9D said Kelly Knupp, M.D., M=
SCS, FAES, Associate Professor, Children=E2=80=99s Hospital Colorado, USA. =
=E2=80=9CAs a complementary therapy, fenfluramine offers a different mechan=
ism of action and demonstrated ability to significantly reduce the number o=
f seizures associated with a drop, a critical measure for managing this sev=
ere form of epilepsy.=E2=80=9D=C2=A0
UCB is committed to supporting patient access to fenfluramine, and as part =
of that commitment, Zogenix Central, a comprehensive support program, will =
provide ongoing product assistance to patients, caregivers, and their medic=
al teams. Further information is available at www.FINTEPLA.com (http://www.=
fintepla.com/) .
=E2=80=9CLGS is a severe, life-long disease with wide-ranging effects beyon=
d seizures. It impacts every aspect of daily life and puts great strain on =
the entire family. There is a desperate need for more effective treatment o=
ptions,=E2=80=9D said Dr. Tracy Dixon-Salazar, Executive Director of the Le=
nnox-Gastaut Syndrome Foundation and mother to an adult daughter with LGS. =
=E2=80=9CThe potential for fenfluramine to make a difference in the daily, =
horrific seizures we are dealing with in LGS cannot be understated. We are =
so grateful for the researchers who have worked so hard to help all of us s=
uffering at the hands of LGS.=E2=80=9D
UCB acquired Zogenix and fenfluramine on March 7, 2022. The acquisition is =
consistent with UCB=E2=80=99s sustainable patient value strategy and contin=
ued commitment to providing world leading patient value to all people livin=
g with epilepsy, with an increasing focus on creating value and new solutio=
ns that address the unmet needs of people with certain specialized or rare =
types of epilepsy, where few or no options exist.
About FINTEPLA^=C2=AE (fenfluramine) C-IV
FINTEPLA^=C2=AE (fenfluramine) oral solution is a prescription medication a=
pproved by the FDA and authorized by the EU Commission, and under regulator=
y review with the PMDA (Japan), for the treatment of seizures associated wi=
th Dravet syndrome in patients two years of age and older.^8,12 A Type II V=
ariation Application has also been submitted to the European Medicines Agen=
cy (EMA) for the treatment of seizures associated with LGS.^13
In the United States, FINTEPLA is available only through a restricted distr=
ibution program called the FINTEPLA REMS program. FINTEPLA is available in =
EU under a controlled access program requested by the EMA to prevent off-la=
bel use for weight management and to confirm that prescribing physicians ha=
ve been informed of the need for periodic cardiac monitoring in patients ta=
king FINTEPLA. Further information is available at www.FinteplaREMS.com or =
by telephone at +1 877 964 3649.=C2=A0
Please see full Prescribing Information (https://www.zogenix.com/pi/Fintepl=
a-prescribing-information.pdf) , including Boxed Warning, for additional im=
portant information on FINTEPLA.
Please refer to Summary of Product Characteristics (https://www.ema.europa.=
eu/en/documents/product-information/fintepla-epar-product-information_en.pd=
f) (SmPC) before prescribing.=C2=A0
Important Safety Information about FINTEPLA^=C2=AE =E2=96=BC=C2=A0in the EU=
and EEA^8
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in=
section 6.1. Aortic or mitral valvular heart disease. Pulmonary arterial h=
ypertension. 4 Within 14 days of the administration of monoamine oxidase in=
hibitors due to an increased risk of serotonin syndrome
Summary of the safety profile=C2=A0
The most commonly reported adverse reactions are decreased appetite (44.2%)=
, diarrhoea (30.8%), pyrexia (25.6%), fatigue (25.6%), upper respiratory tr=
act infection (20.5%), lethargy (17.5%), somnolence (15.4%), and bronchitis=
(11.6%)
Special warnings and precautions for use
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, no valvular=
heart disease was observed.
Prior to starting treatment, patients must undergo an echocardiogram to est=
ablish a baseline prior to initiating treatment (see section 4.3) and exclu=
de any pre-existing valvular heart disease or pulmonary hypertension.
Echocardiogram monitoring should be conducted every 6 months for the first =
2 years and annually thereafter. If an echocardiogram indicates pathologica=
l valvular changes, a follow-up echocardiogram should be considered at an e=
arlier timeframe to evaluate whether the abnormality is persistent. If path=
ological abnormalities on the echocardiogram are observed, it is recommende=
d to evaluate the benefit versus risk of continuing fenfluramine treatment =
with the prescriber, caregiver, and cardiologist.
If treatment is stopped because of aortic or mitral valvular heart disease,=
appropriate monitoring and follow-up should be provided in accordance with=
local guidelines for the treatment of aortic or mitral valvular heart dise=
ase.
With past use in higher doses to treat adult obesity, fenfluramine was repo=
rted to be associated with pulmonary arterial hypertension. Pulmonary arter=
ial hypertension was not observed in the clinical programme, but because of=
the low incidence of this disease, the clinical trial experience with fenf=
luramine is inadequate to determine if fenfluramine increases the risk for =
pulmonary arterial hypertension in patients with Dravet syndrome. If echoca=
rdiogram findings are suggestive of pulmonary arterial hypertension, a repe=
at echocardiogram should be performed as soon as possible and within 3 mont=
hs to confirm these findings. If the echocardiogram finding is confirmed su=
ggestive of an increased probability of pulmonary arterial hypertension def=
ined as =E2=80=9Cintermediate probability=E2=80=9D by the 2015 European Soc=
iety of Cardiology (ESC) and the European Respiratory Society (ERS) Guideli=
nes, it should lead to a benefit-risk evaluation of continuation of Fintepl=
a by the prescriber, carer, and cardiologist. If the echocardiogram finding=
, after confirmation, suggests of a high probability of pulmonary arterial =
hypertension, as defined by the 2015 ESC and ERS Guidelines, it is recommen=
ded fenfluramine treatment should be stopped.
Decreased appetite and weight loss
Fenfluramine can cause decreased appetite and weight loss (see section 4.8)=
. An additive effect on decreased appetite can occur when fenfluramine is c=
ombined with other anti-epileptic medicines, for example stiripentol. The d=
ecrease in weight appears to be dose related. Most subjects resumed weight =
gain over time while continuing treatment. The patient's weight should be m=
onitored. A benefit risk evaluation should be undertaken prior to commencin=
g treatment with fenfluramine in patients with a history of anorexia nervos=
a or bulimia nervosa.
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.
Somnolence
Fenfluramine can cause somnolence.
Other central nervous system depressants, including alcohol, could potentia=
te the somnolence effect of fenfluramine (see sections 4.5 and 4.7).
Suicidal behaviour and ideation
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 (see sections 4.3 and 4.5).
Serotonin syndrome symptoms may include mental status changes (eg, agitatio=
n, hallucinations, coma), autonomic instability (eg, tachycardia, labile bl=
ood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, =
incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, di=
arrhoea).
If concomitant treatment with fenfluramine and other serotonergic agents th=
at may affect the serotonergic systems is clinically warranted, careful obs=
ervation of the patient is advised, particularly during treatment initiatio=
n 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.
Cyproheptadine
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's 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.
Strong CYP1A2 or CYP2B6 inducers
Co-administration with strong CYP1A2 inducers or CYP2B6 inducers may decrea=
se fenfluramine plasma concentrations (see section 4.5).
An increase in fenfluramine dosage should be considered when co-administere=
d with a strong CYP1A2 or CYP2B6 inducer; the maximum daily dose should not=
be exceeded.
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 hyper=
sensitivity reactions and bronchospasm.
Patients with rare glucose-galactose malabsorption should not take this med=
icinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per the max=
imum daily dose of 12 mL, that is to say essentially 'sodium-free'.
This medicinal product contains glucose which may be harmful to the teeth.
Refer to the European Summary of Product Characteristics for other adverse =
reactions and full prescribing information. Date of revision: 04 Nov 2021.=
=C2=A0
https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-pr=
oduct-information_en.pdf=C2=A0
=C2=A0=E2=96=BCThis medicinal product is subject to additional monitoring. =
This will allow quick identification of new safety information. Healthcare =
professionals are asked to report any suspected adverse reactions.=C2=A0
Important Safety Information about FINTEPLA^=C2=AE in the US^9
INDICATIONS AND USAGE
FINTEPLA is indicated for the treatment of seizures associated with Dravet =
syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age =
and older.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION
=C2=B7 There is an association between serotonergic drugs with 5-HT2B recep=
tor agonist activity, including fenfluramine (the active ingredient in FINT=
EPLA), and valvular heart disease and pulmonary arterial hypertension.=C2=
=A0
=C2=B7 Echocardiogram assessments are required before, during, and after tr=
eatment with FINTEPLA.=C2=A0
=C2=B7 FINTEPLA is available only through a restricted program called the F=
INTEPLA REMS.
CONTRAINDICATIONS
FINTEPLA is contraindicated in patients with hypersensitivity to fenflurami=
ne or any of the excipients in FINTEPLA and with concomitant use, or within=
14 days of the administration of monoamine oxidase inhibitors because of a=
n increased risk of serotonin syndrome.
WARNINGS AND PRECAUTIONS
Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warni=
ng): Because of the association between serotonergic drugs with 5 HT2B rece=
ptor agonist activity, including fenfluramine (the active ingredient in FIN=
TEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertensio=
n (PAH), cardiac monitoring via echocardiogram is required prior to startin=
g treatment, during treatment, and after treatment with FINTEPLA concludes.=
Cardiac monitoring via echocardiogram can aid in early detection of these =
conditions. In clinical trials for DS and LGS of up to 3 years in duration,=
no patient receiving FINTEPLA developed VHD or PAH.
Monitoring: Prior to starting treatment, patients must undergo an echocardi=
ogram to evaluate for VHD and PAH. Echocardiograms should be repeated every=
6 months, and once at 3-6 months post treatment with FINTEPLA.
The prescriber must consider the benefits versus the risks of initiating or=
continuing treatment with FINTEPLA if any of the following signs are obser=
ved via echocardiogram: valvular abnormality or new abnormality; VHD indica=
ted by mild or greater aortic regurgitation or moderate or greater mitral r=
egurgitation, with additional characteristics of VHD (eg, valve thickening =
or restrictive valve motion); PAH indicated by elevated right heart/pulmona=
ry artery pressure (PASP >35mmHg).
FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only throu=
gh a restricted distribution program called the FINTEPLA Risk Evaluation an=
d Mitigation Strategy (REMS) Program. Prescribers must be certified by enro=
lling in the FINTEPLA REMS. Prescribers must counsel patients receiving FIN=
TEPLA about the risk of valvular heart disease and pulmonary arterial hyper=
tension, how to recognize signs and symptoms of valvular heart disease and =
pulmonary arterial hypertension, the need for baseline (pretreatment) and p=
eriodic cardiac monitoring via echocardiogram during FINTEPLA treatment, an=
d cardiac monitoring after FINTEPLA treatment. Patients must enroll in the =
FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy=
must be certified by enrolling in the FINTEPLA REMS and must only dispense=
to patients who are authorized to receive FINTEPLA. Wholesalers and distri=
butors must only distribute to certified pharmacies. Further information is=
available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.
Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in ap=
petite and weight. Decreases in weight appear to be dose related. Approxima=
tely half of the patients with LGS and most patients with DS resumed the ex=
pected measured increases in weight during the open-label extension studies=
. Weight should be monitored regularly during treatment with FINTEPLA, and =
dose modifications should be considered if a decrease in weight is observed=
.=C2=A0
Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation=
, and lethargy. Other central nervous system (CNS) depressants, including a=
lcohol, could potentiate these effects of FINTEPLA. Prescribers should moni=
tor patients for somnolence and sedation and should advise patients not to =
drive or operate machinery until they have gained sufficient experience on =
FINTEPLA to gauge whether it adversely affects their ability to drive or op=
erate machinery.
Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTE=
PLA, increase the risk of suicidal thoughts or behaviors in patients taking=
these drugs for any indication. Patients treated with an AED for any indic=
ation should be monitored for the emergence or worsening of depression, sui=
cidal thoughts or behaviors, or any unusual changes in mood or behavior.
Anyone considering prescribing FINTEPLA or any other AED must balance the r=
isk of suicidal thoughts or behaviors with the risks of untreated illness. =
Epilepsy and many other illnesses for which AEDs are prescribed are themsel=
ves associated with morbidity and mortality and an increased risk of suicid=
al thoughts and behaviors. Should suicidal thoughts and behaviors emerge du=
ring treatment, consider whether the emergence of these symptoms in any giv=
en patient may be related to the illness being treated.
Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should gener=
ally be withdrawn gradually because of the risk of increased seizure freque=
ncy and status epilepticus. If withdrawal is needed because of a serious ad=
verse reaction, rapid discontinuation can be considered.
Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening cond=
ition, may occur with FINTEPLA, particularly during concomitant administrat=
ion of FINTEPLA with other serotonergic drugs, including, but not limited t=
o, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selectiv=
e serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), =
bupropion, triptans, dietary supplements (eg, St. John=E2=80=99s Wort, tryp=
tophan), drugs that impair metabolism of serotonin (including monoamine oxi=
dase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextrome=
thorphan, lithium, tramadol, and antipsychotics with serotonergic agonist a=
ctivity. Patients should be monitored for the emergence of signs and sympto=
ms of serotonin syndrome, which include mental status changes (eg, agitatio=
n, hallucinations, coma), autonomic instability (eg, tachycardia, labile bl=
ood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoor=
dination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea=
). If serotonin syndrome is suspected, treatment with FINTEPLA should be st=
opped immediately and symptomatic treatment should be started.=C2=A0
Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressur=
e. Rare cases of significant elevation in blood pressure, including hyperte=
nsive crisis, has been reported in adult patients treated with fenfluramine=
, including patients without a history of hypertension. In clinical trials =
for DS and LGS of up to 3 years in duration, no pediatric or adult patient =
receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in=
patients treated with FINTEPLA.
Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closur=
e glaucoma. Consider discontinuing treatment with FINTEPLA in patients with=
acute decreases in visual acuity or ocular pain.
ADVERSE REACTIONS
The most common adverse reactions observed in DS studies (incidence at leas=
t 10% and greater than placebo) were decreased appetite; somnolence, sedati=
on, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, mal=
aise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure =
increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tr=
act infection; vomiting; decreased weight; fall; status epilepticus.
The most common adverse reactions observed in the LGS study (incidence at l=
east 10% and greater than placebo) were diarrhea; decreased appetite; fatig=
ue; somnolence; vomiting.
DRUG INTERACTIONS
Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1=
A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrati=
ons. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with =
FINTEPLA is necessary, monitor the patient for reduced efficacy and conside=
r increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, =
or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA=
, consider gradual reduction in the FINTEPLA dosage to the dose administere=
d prior to initiating the inducer.
Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or =
CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINT=
EPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum=
daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor =
is discontinued during maintenance treatment with FINTEPLA, consider gradua=
l increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or=
CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a st=
rong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17=
mg.
USE IN SPECIFIC POPULATIONS
Administration to patients with hepatic impairment is not recommended.=C2=
=A0
To report SUSPECTED ADVERSE REACTIONS, contact Zogenix Inc. at 1-866-964-36=
49 (1-866-Zogenix) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information (https://zogenix.com/pi/Fintepla-pr=
escribing-information.pdf) , including Boxed Warning, for additional import=
ant information on FINTEPLA.
----------------------------------------------------------------------
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.9414
antje.witte@ucb.com
Corporate Communications
Laurent Schots, Media Relations
T+32.2.559.9264
Laurent.schots@ucb.com =C2=A0 =C2=A0
Nick Francis=C2=A0
T +44 7769 307745
Nick.francis@ucb.com
=C2=A0=C2=A0 =C2=A0
Erica Puntel, U.S. Media Relations
T +404 938 5359
Erica.puntel@ucb.com
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 8 600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Fol=
low us on Twitter: @UCB_news.=C2=A0
Forward looking statements=C2=A0
This press release contains forward-looking statements including, without l=
imitation, 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=9Cestimate=
s=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccontinu=
e=E2=80=9D and similar expressions. These forward-looking statements are ba=
sed on current plans, estimates and beliefs of management. All statements, =
other than statements of historical facts, are statements that could be dee=
med forward-looking statements, including but not limited to, the ability o=
f UCB to successfully integrate the operations of Zogenix as planned or at =
all, estimates of revenues, operating margins, capital expenditures, cash, =
other financial information, expected legal, arbitration, political, regula=
tory or clinical results or practices and other such estimates and results.=
By their nature, such forward-looking statements are not guarantees of fut=
ure performance and are subject to known and unknown risks, uncertainties a=
nd assumptions which might cause the actual results, financial condition, p=
erformance or achievements of UCB, or industry results, to differ materiall=
y from those that may be expressed or implied by such forward-looking state=
ments contained in this press release. Important factors that could result =
in such differences include: the global spread and impact of COVID-19, chan=
ges in general economic, business and competitive conditions, the inability=
to obtain necessary regulatory approvals or to obtain them on acceptable t=
erms or within expected timing, costs associated with research and developm=
ent, changes in the prospects for products in the pipeline or under develop=
ment by UCB, effects of future judicial decisions or governmental investiga=
tions, safety, quality, data integrity or manufacturing issues; potential o=
r actual data security and data privacy breaches, or disruptions of our inf=
ormation technology systems, product liability claims, challenges to patent=
protection for products or product candidates, competition from other prod=
ucts including biosimilars, changes in laws or regulations, exchange rate f=
luctuations, changes or uncertainties 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 be discovered or identified in the pipeli=
ne, or that new indications for existing products will be developed and app=
roved. Movement from concept to commercial product is uncertain; preclinica=
l results do not guarantee safety and efficacy of product candidates in hum=
ans. So far, the complexity of the human body cannot be reproduced in compu=
ter models, cell culture systems or animal models. The length of the timing=
to complete clinical trials and to get regulatory approval for product mar=
keting has varied in the past and UCB expects similar unpredictability goin=
g forward. Products or potential products which are the subject of partners=
hips, joint ventures or licensing collaborations may be subject to disputes=
between the partners or may prove to be not as safe, effective or commerci=
ally successful as UCB may have believed at the start of such partnership. =
UCB=E2=80=99 efforts to acquire other products or companies and to integrat=
e the operations of such acquired companies may not be as successful as UCB=
may have believed at the moment of acquisition. Also, UCB or others could =
discover safety, side effects or manufacturing problems with its products a=
nd/or devices after they are marketed. The discovery of significant problem=
s 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 on sales of th=
e entire class of affected products. Moreover, sales may be impacted by int=
ernational and domestic trends toward managed care and health care cost con=
tainment, including pricing pressure, political and public scrutiny, custom=
er and prescriber patterns or practices, and the reimbursement policies imp=
osed by third-party payers as well as legislation affecting biopharmaceutic=
al pricing and reimbursement activities and outcomes. Finally, a breakdown,=
cyberattack or information security breach could compromise the confidenti=
ality, integrity and availability of UCB=E2=80=99s data and systems.
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.
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release and expressly disclaims any duty to=
update any information contained in this press release, either to confirm =
the actual results or to report or reflect any change in its forward-lookin=
g statements with regard thereto or any change in events, conditions or cir=
cumstances on which any such statement is based, unless such statement is r=
equired pursuant to applicable laws and regulations.
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. FINTEPLA^=C2=AE (fenfluramine) oral solution CIV. U.S. Prescribing Infor=
mation. March 2022.
2. Wirrell E, Nickels KC. Pediatric epilepsy syndromes. Continuum (Minneap =
Minn). 2010;16(3 Epilepsy):57-85.
3. Mastrangelo M. Lennox-Gastaut Syndrome: A State of the Art Review. Neuro=
pediatrics. 2017;48(3):143-151.=C2=A0
4. 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.=C2=A0
5. Arzimanoglou A, French J, Blume WT, et al. Lennox-Gastaut syndrome: a co=
nsensus approach on diagnosis, assessment, management, and trial methodolog=
y. Lancet Neurol. 2009;8(1):82-93.
6. Data on file, Zogenix, Inc. 2021.
7. Data on file, Zogenix, Inc. 2021.
8. FINTEPLA Summary of Product Characteristics. January 2022.
9. LGS Foundation. LGS Characteristics and Major Concerns Survey. https://w=
ww.lgsfoundation.org/wp-content/uploads/2021/08/2019-PFDD-Caregiver-Survey-=
1.pdf. Accessed March 2022.
10. Harden C, Tomson T, et al. Practice guideline summary: Sudden unexpecte=
d death in epilepsy incidence rates and risk factors: Report of the Guideli=
ne Development, Dissemination, and Implementation Subcommittee of the Ameri=
can Academy of Neurology and the American Epilepsy Society. Neurology. 2017=
Apr 25;88(17):1674-1680.=C2=A0
11. Data on file, Zogenix, Inc.
12. Zogenix Press Release. Zogenix Submits New Drug Application for FINTEPL=
A^=C2=AE (Fenfluramine) in Japan for the Treatment of Epileptic Seizures As=
sociated with Dravet Syndrome. 21 December 2021.
13. Zogenix Press Release. Zogenix Submits Type II Variation Application to=
the European Medicines Agency (EMA) to Expand the Use of FINTEPLA^=C2=AE (=
fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut =
Syndrome. Accessed 20 December 2021.
GenericFile
220327 GLOBAL Fintepla LGS FDA Approval PR FINAL ENG (https://mb.cision.com=
/Public/18595/3533352/b5d07d4101b91e32.pdf)
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