UCB showcases commitment to transforming outcomes for people living with epilepsy and rare epileptic syndromes at European Pediatric Neurology Society (EPNS) Annual Congress

Brussels, Belgium, 20 June 2023 – 07.00 AM CET – UCB will share the latest data from its epilepsy and rare epilepsy syndrome portfolio at the European Pediatric Neurology Society Annual Congress, June 20-24, 2023. The company will present seven abstracts, including one podium presentation, at the congress, across Dravet syndrome, Lennox-Gastaut syndrome (LGS), and focal (partial) epileptic seizures.

Mike Davis, Head of Global Epilepsy & Rare Syndromes, UCB, said: “At UCB, we aim to positively impact individuals, carers, and families living with epilepsies, through differentiated solutions, and we look forward to discussing our latest patient-centred data at EPNS. We continue to pioneer new research to better understand the fundamental mechanisms of the underlying different forms of epilepsy to foster discovery and development of potential disease modifying or even curative therapies, and the theme of the congress this year – ‘From genome and connectome to cure’ – aligns perfectly with our ambitions.”

In LGS, the presentation of questionnaire survey data from a collaboration between Zogenix (now part of UCB) and the European Collaboration for Epilepsy Trials (ECET) Consortium, assessing the unmet medical needs of patients¹ will be complemented by interim results from a European real-world study of patients with LGS.² Between these two presentations, unmet needs and associated disease burden in LGS will be examined from both patient and clinical perspectives. The ECET survey illustrates the difficulty in managing LGS patients, finding that 69% (n=61 centres) of centres trialled five to ten anti-seizure medications and 18% of centres trialled more than ten such medications in their search for an effective regimen for each patient.¹ 

In Dravet syndrome, post-hoc pooled responder data from two identical phase 3 trials of fenfluramine, have been analysed in order to estimate the number-needed-to-treat (NNT) to reach clinically meaningful response thresholds³. With no head-to-head comparative trials in therapies approved for Dravet syndrome, these results may be used to guide clinical treatment decisions.³ Data presented on fenfluramine also include a review of published studies of its effectiveness in reducing the frequency of generalized tonic-clonic (GTC) seizures in patients with rare epilepsy syndromes.⁴ GTC seizures are a primary risk factor of sudden unexpected death in epilepsy (SUDEP).⁵ 

In focal epileptic seizures, data from EXPERIENCE - a pooled analysis of retrospective cohorts - will be presented, evaluating the safety profile, tolerability, and efficacy of brivaracetam in pediatric patients in routine clinical practice⁶. In addition, data on long-term (mean exposure 3.2 patient years) safety profile, tolerability, and efficacy, as well as the cognitive and behavioural impact of the treatment, will be shared.^7,8

Ana Infante, Head of Epilepsy and European Operations said: “Our commitment to epilepsy research has never been stronger, and the presentations at EPNS speak to the depth of our data, and the variety of perspectives, clinical and patient, which we seek. Deeper insights on unmet needs within our therapy areas, such as those of people living with Dravet syndrome and Lennox-Gastaut syndrome, help us to target future research, and set our sights on addressing the issues in developmental and epileptic encephalopathies which impact the lives of patients every day.”

Industry-sponsored symposium discussing developmental epileptic encephalopathies (DEEs)
‘Dravet syndrome and Lennox-Gastaut syndrome: what’s next in practice?’, on Thursday 22nd June 13.00-14.00 (CEST) will elevate knowledge and awareness of the impact of DEEs, and the application of the latest clinical data to clinical practice through real-world case study discussion.

UCB presentations during EPNS 2023

About BRIVIACT^® (brivaracetam) in the EU⁹

Important Safety Information about BRIVIACT in the EU 
BRIVIACT (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Contraindications Hypersensitivity to the active substance, other pyrrolidone derivatives or any of the excipients. 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.  Patients should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge. BRIVIACT film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase 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 respectively, that is to say essentially ‘sodium free’. The oral solution contains 168 mg sorbitol (E420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Brivaracetam oral solution contains propylene glycol (E1520). 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 patients with impaired renal function. No clinical data are available in paediatric patients with renal impairment. In patients with hepatic impairment, the following adjusted doses, administered in 2 divided doses, approximately 12 hours apart, are recommended for all stages of hepatic impairment: In adults, adolescents and children weighing ≥50 kg, a 50 mg/day starting dose is recommended, with a maximum daily dose of 150 mg/day. For adolescents 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 in paediatric patients with hepatic impairment. 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 continuous infusion in healthy subjects there was no pharmacokinetic interaction, but the effect of alcohol on psychomotor function, attention and memory 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, co-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 patients starting or ending treatment with rifampicin. Other strong enzyme-inducers (such as St John´s wort [Hypericum perforatum]) may also decrease the systemic exposure of BRIVIACT. Therefore, starting or ending treatment with St John’s wort should be done with caution. In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19. Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g., lansoprazole, omeprazole, diazepam). CYP2B6 induction has not been investigated in vivo and BRIVIACT may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro studies have also shown that BRIVIACT has inhibitory effects on OAT3. BRIVIACT 200 mg/day may increase plasma concentrations of medicinal products transported by OAT3. BRIVIACT plasma concentrations are decreased when co-administered with strong enzyme inducing antiepileptic drugs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required. Effects on ability to drive and use machines BRIVIACT, has minor or moderate influence on the ability to drive and use machines. 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. 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 usually mild to moderate in intensity. Somnolence and fatigue were reported at higher incidences with increasing dose. Very common adverse reactions (≥1% to <10%) were influenza, decreased appetite, depression, anxiety, insomnia, irritability, convulsion, vertigo, upper respiratory tract infections, cough, nausea, vomiting, constipation and fatigue. Neutropenia has been reported in 0.5% (6/1,099) BRIVIACT patients and 0% (0/459) placebo-treated patients. Four of these patients had decreased neutrophil counts at baseline, and experienced additional decrease in neutrophil counts after initiation of BRIVIACT. None of the six cases were severe, required any specific treatment, led to BRIVIACT discontinuation, or had associated infections. Suicidal ideation was reported in 0.3 % (3/1099) of BRIVIACT treated patients 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 completed suicide and suicide attempt, however both were reported in the long-term open-label extension studies. Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of BRIVIACT patients (9/3022) during clinical development. The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients assessed from 6 years onwards (more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults. The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7 %). No specific pattern of adverse event (AE) was identified in children from 1 month to < 4 years of age when compared to older paediatric age groups. No significant safety information was identified indicating the increasing incidence of a particular AE in this age group. As data available in children younger than 2 years of age are limited, brivaracetam is not indicated in this age range. No clinical data are available in neonates. Overdose There is limited clinical experience with BRIVIACT overdose in humans. Somnolence and dizziness were reported in a healthy subject taking a single dose of 1,400 mg of BRIVIACT. The following adverse reactions were reported with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation in the post-marketing experience. In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions. There is no specific antidote. Treatment of an overdose should include general supportive measures. Since less than 10% of BRIVIACT is excreted in urine, haemodialysis is not expected to significantly enhance BRIVIACT clearance.

Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. 
https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf

About FINTEPLA^®▼(fenfluramine) oral solution in EU¹⁰

FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older. Fenfluramine is a serotonin releasing agent, and thereby stimulates multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor. The precise mode of action of fenfluramine in Dravet syndrome and Lennox-Gastaut syndrome is not known.

Fenfluramine oral solution is available under a controlled access program to ensure regular cardiac monitoring and to mitigate potential off-label use.

Please refer to Fintepla, INN-Fenfluramine (europa.eu) (SmPC) before prescribing.

▼This 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.

Important Safety Information about FINTEPLA^®▼ in EU

Aortic or mitral valvular heart disease and pulmonary arterial hypertension
Because of reported cases of valvular heart disease that may have been caused by fenfluramine at higher doses used to treat adult obesity, cardiac monitoring must be performed using echocardiography. In the controlled clinical studies of fenfluramine for the treatment of Dravet syndrome and Lennox-Gastaut 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 disease or pulmonary hypertension. Echocardiogram monitoring should be conducted every 6 months for the first 2 years and annually thereafter. If an echocardiogram indicates pathological valvular changes, a follow-up echocardiogram should be considered at an earlier timeframe to evaluate whether the abnormality is persistent. If pathological abnormalities on the echocardiogram are observed, it is recommended 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 disease. With past use in higher doses to treat adult obesity, fenfluramine was reported to be associated with pulmonary arterial hypertension. Pulmonary arterial hypertension was not observed in the clinical programme, but because of the low incidence of this disease, the clinical trial experience with fenfluramine is inadequate to determine if fenfluramine increases the risk for pulmonary arterial hypertension in patients with Dravet syndrome and Lennox-Gastaut syndrome. If echocardiogram findings are suggestive of pulmonary arterial hypertension, a repeat echocardiogram should be performed as soon as possible and within 3 months to confirm these findings. If the echocardiogram finding is confirmed suggestive of an increased probability of pulmonary arterial hypertension defined as “intermediate probability” 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 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 recommended fenfluramine treatment should be stopped.

Decreased appetite and weight loss 

Fenfluramine can cause decreased appetite and weight loss. An additive effect 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 while continuing treatment. The patient's weight should be monitored. A benefit risk evaluation should be undertaken prior to commencing treatment with fenfluramine in patients with a history of anorexia nervosa 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 physicians have been informed of the need for periodic cardiac monitoring in patients taking Fintepla. 

Somnolence

Fenfluramine can cause somnolence. Other central nervous system depressants, including alcohol, could potentiate the somnolence effect of fenfluramine.

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 randomised placebo-controlled trials with anti-epileptic medicines that did not include fenfluramine has shown a small increased risk of suicidal behaviour and ideation. The mechanism of this risk is not known, and the available data do not exclude the possibility of an increased risk for fenfluramine. Patients 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-threatening condition, may occur with fenfluramine treatment, particularly with concomitant use of other serotonergic agents (including SSRIs, SNRIs, tricyclic antidepressants, or triptans); with agents that impair metabolism of serotonin such as MAOIs; or with antipsychotics that may affect the serotonergic neurotransmitter systems. Serotonin syndrome symptoms may include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular 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 advised, particularly during treatment initiation and dose increases.

Increased seizure frequency

As with other anti-epileptic medicines, a clinically relevant increase in seizure frequency may occur during treatment with fenfluramine, which may require adjustment in the dose of fenfluramine and/or concomitant anti-epileptic 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 treatment with fenfluramine, patients should be monitored for worsening of seizures. If fenfluramine treatment is initiated in a patient taking cyproheptadine, 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. Consider 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 decrease fenfluramine plasma concentrations, which may lower the efficacy of fenfluramine. If co-administration of a strong CYP1A2 or CYP2B6 inducer with fenfluramine is considered necessary, the patient should be monitored for reduced efficacy and a dose increase of fenfluramine could be considered provided that it does not exceed twice the maximum daily dose (52 mg/day). If a strong CYP1A2 or CYP2B6 inducer is discontinued during maintenance treatment 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 inhibitor may result in higher exposure and, therefore, adverse events should be monitored, and a dose reduction may be needed in some patients.

Coadministration of a single 0.35 mg/kg dose of fenfluramine with fluvoxamine (a strong CYP1A2 inhibitor) at steady state (50 mg once daily) in healthy volunteers increased the AUC0-t of fenfluramine by a ratio of 2.1-fold and the Cmax by a ratio of 1.2-fold, and decreased the AUC0-t of norfenfluramine by a ratio of 1.3-fold and the Cmax by a ratio of 1.4-fold, as compared to fenfluramine administered alone. 

Coadministration of a single 0.35 mg/kg dose of fenfluramine with paroxetine (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 norfenfluramine 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) and sodium methyl para hydroxybenzoate (E 219) which may cause allergic reactions (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 product. This medicinal product contains less than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL, that is to say essentially ‘sodium-free’. This medicinal product contains glucose which may be harmful to the teeth.

BRIVIACT^® and FINTEPLA^® are registered trademarks of the UCB Group of Companies.

For further information, contact UCB: 

Global Communications
Nick Francis
T +44 7769 307745
email nick.francis@ucb.com  

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 
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

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References:

1. Tchaicha S, Arzimanoglou A, Holmes E, et al. Assessment of the Unmet Medical Needs of Patients With Lennox-Gastaut Syndrome: A Survey in Collaboration With the European Collaboration for Epilepsy Trials Consortium. Abstract 2636 presented at European Paediatric Neurology Society (EPNS), Prague, Czech Republic, 20-24 June 2023.
2. Strzelczyk A, Gil-Nagel A, Striano P, et al. Lennox-Gastaut Syndrome characteristics: Interim results from a European real-world point-in-time study. Abstract 2109 presented at European Paediatric Neurology Society (EPNS), Prague, Czech Republic, 20-24 June 2023.
3. Wheless JW, Dai D, Gammaitoni AR, et al. Fenfluramine Responder Analysis and Numbers Needed to Treat: Post-Hoc Pooled Analysis of Two Phase 3 Studies in Dravet Syndrome. Abstract MP06-2635 presented at European Paediatric Neurology Society (EPNS), Prague, Czech Republic, 20-24 June 2023.
4. Cross H, Devinsky O, Gil-Nagel A. Effect of Fenfluramine on Generalized Tonic-Clonic Seizures in Rare Epilepsy Syndromes: A Review of Published Studies. Abstract PA03-2633 presented at European Paediatric Neurology Society (EPNS), Prague, Czech Republic, 20-24 June 2023.
5. Harden C, Tomson T, Gloss D, et al. Practice Guideline Summary: Sudden Unexpected Death in Epilepsy Incidence Rates and Risk Factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Epilepsy Curr. 2017;17(3):180-187. 
6. Soto Insuga V, D'Souza W, Faught E, et al. 12-Month Effectiveness and Tolerability of Brivaracetam in Pediatric Patients in the Real-World: Subgroup Data From the EXPERIENCE Analysis. Abstract PO04-2117 presented at European Paediatric Neurology Society (EPNS), Prague, Czech Republic, 20-24 June 2023.
7. Klotz A, Lagae L, Fogarasi A, et al. Long-term Safety and Efficacy of Adjunctive Brivaracetam in Pediatric Patients with Epilepsy: An Open-label, Follow-up Trial. Abstract P: PO04-2119 presented at European Paediatric Neurology Society (EPNS), Prague, Czech Republic, 20-24 June 2023.
8. Elshoff JP, Fleyshman S, De La Loge C, et al. Cognitive and Behavioral Effects of Adjunctive Brivaracetam in Children and Adolescents with Focal Seizures: Final Data From an Open-label Follow-up Trial. P: PO04-2118 presented at European Paediatric Neurology Society (EPNS), Prague, Czech Republic, 20-24 June 2023. 
9. Briviact® EU SmPC. https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf Accessed on May 2023.
10. Fintepla® EU SmPC. https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf. Accessed on May 2023.