Fenfluramine Hydrochloride

Substantial impact of sleep disturbances: New interim caregiver survey results found that a quarter of patients with developmental and epileptic encephalopathies (DEEs) experienced daily sleep disturbances, leading to a negative impact on activities of daily living and communication.1 Impact of prolonged seizures: Results from global real-world data illustrate the impacts of prolonged seizures on both people living with epilepsy and their caregivers, with 88% and 96%, respectively, reporting that seizures impacted their ability to perform normal daily activities.2,3 Benefits of persistence: Claims analysis data evaluating treatment persistence with FINTEPLA®4 (fenfluramine) for people in the U.S. living with Lennox-Gastaut syndrome (LGS) show reductions in healthcare resource utilization and antiseizure medication claims for patients with treatment persistence at 6 and 12 months.5 ATLANTA, April 15, 2026 /PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today presented new global, real-world, patient-centric data, including data from a study assessing the impacts on quality of life that developmental and epileptic encephalopathies (DEEs) have on individuals and caregivers, as well as the impact of living with prolonged seizures on patients and their caregivers. The company is presenting 21 abstracts in total from its innovative neurology portfolio (14 epilepsy and 7 rare disease including 6 myasthenia gravis (MG) abstracts) at the American Academy of Neurology (AAN) 2026 Annual Meeting (April 18-22, 2026). Continue Reading FINTEPLA® (fenfluramine) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients two years of age and older. (PRNewsfoto/UCB) New interim survey results demonstrated the impacts of sleep disturbances on activities of daily living (ADL) and communication 1 Caregivers of people living with DEEs (n=489) – rare, severe, and lifelong epileptic syndromes6 – completed an anonymous 63-question survey, providing information on sleep disruptions and their impact on ADLs and communication. Results demonstrated that 9.6% of patients' (n=47) sleep was "unpredictable with no typical pattern," while daily disruptive sleep was experienced by over a quarter of patients (27.0%; n=132). These sleep disturbances in approximately a quarter of patients (24.5%; n=120) were associated with temporary loss of one or more ADLs and temporary loss of communication (21.5%; n=105), further underlining the impacts of sleep disruptions for these patients and their caregivers. "Many people living with developmental and epileptic encephalopathies, or DEEs, experience significant sleep problems and behavioral difficulties, which can have real and long-lasting impacts on quality of life," said Andrea Wilkinson, Global Head of Patient Engagement & Advocacy, Epilepsy & Neuromuscular, and lead author of the study. "These results demonstrate the clear relationship between disrupted sleep and temporary losses in daily function and communications, underscoring the importance of addressing disease impacts beyond seizure alone and continuing to prioritize sleep as an endpoint in future research to improve outcomes." Prolonged seizures impacted both patients and their caregivers' ability to perform daily activities with negative impacts on anxiety and depression 2 , 3 Self-reported data from both people living with epilepsy and their caregivers illustrated the impacts of prolonged seizures. 88% of patients (n=438/498) and 96% of caregivers (n=270/282) reported that these seizures had impacted their ability to perform normal daily activities. Among patients (n=196) and caregivers (n=107), an average of 2.9 and 2.6 work hours per week, respectively, were missed due to prolonged seizures. Additionally, 79% of patients (n=181/229) and 94% of caregivers (n=157/167) reported that prolonged seizures negatively impacted their work productivity. Seizure worry also impacted both patients and caregivers, with over half of patients (58%; n=292/506) reporting they were at least slightly anxious/depressed, and almost a quarter (24%; n=62/263) of caregivers reporting a health condition developing or worsening due to their care of a patient with prolonged seizures. A U.S. subgroup analysis of 545 patients with epilepsy who experienced ≥1 prolonged seizure (PS) evaluated seizure events, treatment use, healthcare resource utilization (HCRU), and overall disease burden. In this subgroup, 70% of patients were currently prescribed a rescue medication, 67% had a seizure action plan in place, and a higher proportion of patients required HCRU for their PS than their non-PS events. Seizure clusters and injuries were more commonly experienced among patients with PS events compared with non-PS events (14% vs. 9% and 21% vs. 17%, respectively), underscoring the need for additional treatment options to help prevent progression to more severe seizure states. Treatment persistence with fenfluramine led to reductions in Healthcare Resource Utilization and antiseizure medication burden for people living with LGS in the U.S. 5 Results from a retrospective analysis of people living with LGS in the U.S. using the Komodo U.S. healthcare claims database demonstrated that initiating fenfluramine was associated with reductions in HCRU and antiseizure medication (ASM) burden. Among patients with 12 months of fenfluramine continuous claims data before and after initiation (n=148), all-cause inpatient hospitalization claims decreased (mean 4.0 pre vs. 3.1 post; p=0.04), alongside reductions in seizure-related inpatient hospitalization claims (−23.6%; p=0.04), all-cause emergency room (ER) visit claims (−42.4%; p<0.01), seizure-related ER visit claims (−46.4%; p<0.01), and ambulance use claims (−61.8%; p<0.01). Patients who met the primary endpoint also experienced decreases in all ASM claims (−9.3%; p<0.01) and the average number of unique ASMs (−12.2%; p<0.01). In a broader cohort evaluating treatment persistence (n=544) with no fenfluramine gaps >90 days, fenfluramine persistence was 73% at 6 months and 61% at 12 months and the cohort treated with fenfluramine had a greater disease severity as indicated by number of comorbidities and HCRU, compared to the non-fenfluramine-treated cohort. "Families living with LGS manage far more than seizures alone. Fewer emergency room visits, hospitalizations, and ambulance use can translate into less disruption, fewer crises and more stability for families," said Hugo Xi, Head of US Medical Neurology. "Seeing strong treatment persistence over time also reinforces that this therapy is fitting into real lives." For further information, contact UCB: US Communications Becky Malone T +1.919.605.9600 [email protected] Corporate Communications, Media Relations Laurent Schots T +32.2.559.92.64 [email protected] Investor Relations Antje Witte T +32.2.559.94.14 [email protected] Sahar Yazdian T +32.2.559.94.37 [email protected] Yvonne Naughton T +44.175.344.7521 [email protected] About UCB UCB, Brussels, Belgium () 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 more than 9000 people in approximately 40 countries, the company generated revenue of € 7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. Forward-looking statements This document contains forward-looking statements, including, without limitation, statements containing the words "potential", "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. 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Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Indication and Important Safety Information about FINTEPLA ® (fenfluramine) in the US 4 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 FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. FINTEPLA is available only through a restricted program called the FINTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning): FINTEPLA can cause valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Although no patients receiving FINTEPLA developed VHD or PAH in clinical trials for DS and LGS of up to 3 years in duration, cases of VHD and PAH have been reported during use of FINTEPLA in the postmarketing setting. Because of this risk, cardiac monitoring is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can identify evidence of VHD and PAH prior to a patient becoming symptomatic, aiding in early detection of these conditions. Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once 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 observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (e.g., valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35 mm Hg). FINTEPLA REMS (see Boxed Warning): FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS). Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of VHD and PAH, how to recognize signs and symptoms of VHD and PAH, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed. Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor 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 operate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (e.g., St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes, autonomic instability, neuromuscular signs, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started. Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, have 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 closure 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 least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting. To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information , including Boxed Warning and Medication Guide , for additional Important Safety Information on FINTEPLA. References: Wilkinson AL, et al. 2026. AAN. P4.002. Trinka E, et al. 2026. AAN. P4.008. Trinka E, et al. 2026. AAN. Presentation P7.001. FINTEPLA (fenfluramine) oral solution: U.S. prescribing information. Smyrna, GA: UCB, Inc. Kerr WT, et al. 2026. AAN. Presentation P1.005. Lagae L, et al. Quality of life and comorbidities associated with Dravet syndrome severity: a multinational cohort survey. Dev Med Child Neurol. 2018 Jan;60(1):63-72. FINTEPLA® is a registered trademark of the UCB Group of Companies. ©2026 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-FA-2600133 SOURCE UCB 21% more press release views with Request a Demo