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Subjects: Photo/Multimedia, Product/Service

UCB Launches Dravet Syndrome Sound of Profound Moments: Family Video Project


UCB, Inc. (Euronext: UCB), a global biopharmaceutical company, is proud to announce the launch of the FINTEPLA® Sound of Profound Moments: Family Video Project, to help amplify the voices and experiences of FINTEPLA families and loved ones living with Dravet syndrome who have experienced seizure-free moments. The campaign invites the Dravet syndrome community to share videos capturing their everyday moments in life possible with fewer seizures, showcasing the sounds of daily life, conversations and/or milestones that define their unique experience.

In a clinical study, FINTEPLA (0.7 mg/kg/day) reduced monthly seizures by 79% compared to 16% for patients taking a placebo on top of their current antiseizure plans. Results may vary. FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS).

Dravet syndrome, a rare and severe form of epilepsy, presents significant challenges for patients, families, and caregivers, including multiple seizures per day and substantial developmental, motor, and behavioral impairments.1 The FINTEPLA Sound of Profound Moments: Family Video Project encourages families to share their stories, aiming to honor the meaningful everyday moments possible with fewer seizures that make a big difference in the lives of those impacted by Dravet.

"Through the FINTEPLA Sound of Profound Moments: Family Video Project, we aim to shine a light on the moments of joy and connection that emerge with seizure reduction. We continue to be inspired by this amazingly resilient community and are humbled by their unwavering support and compassion. We believe in celebrating the unique sounds that symbolize each family's journey," said Ross Lu, Marketing Lead, Rare Syndromes, Epilepsy US. "At UCB, we are honored to stand alongside these families, amplifying their voices and inspiring others with these special moments and everyday triumphs, both big and small."

"With seizure reduction, we can spend more time at the beach. Callie's able to have friends over. She goes to their house. She's thriving. And we are just so incredibly thankful," said Darlene, mother and caregiver of Callie, who is living with Dravet syndrome. To learn more about the Sound of Profound Campaign and hear more FINTEPLA stories, visit Fintepla.com.

The FINTEPLA Sound of Profound Moments: Family Video Project is open only to residents of the U.S. Campaign details can be found at SoundofProfound.com:

Call for Video Entries:

Sound of Profound Moments Gallery Viewing:

About Dravet Syndrome
Dravet syndrome is a rare, devastating and life-long form of developmental and epileptic encephalopathy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of mortality and sudden unexpected death in epilepsy (SUDEP). Most patients follow a course of developmental delay with cognitive, motor, and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families, and caregivers due to the high physical, emotional, caregiving, and financial burden associated with the disease.1,2,3

About FINTEPLA® (fenfluramine)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.

FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS). Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.

INDICATION

IMPORTANT SAFETY INFORMATION

FINTEPLA can cause serious side effects, including:

1. Problems with the valves in the heart (valvular heart disease) and high blood pressure in the arteries of the lungs (pulmonary arterial hypertension) have been associated with fenfluramine, the active ingredient in FINTEPLA. Your healthcare provider will do a test called an echocardiogram to check your heart and to evaluate for high blood pressure in the arteries of the lungs before you start taking FINTEPLA, again every 6 months during treatment, and one time 3 to 6 months after you take your last dose of FINTEPLA.

Call your healthcare provider right away if you develop any of these signs and symptoms of heart or lung problems during treatment with FINTEPLA:

Because of the risk of heart valve problems (valvular heart disease) and high blood pressure in the arteries of the lungs (pulmonary arterial hypertension), FINTEPLA is only available through a restricted program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Before you or your child receives FINTEPLA, your healthcare provider or pharmacist will make sure you understand how to take FINTEPLA safely. If you have any questions about FINTEPLA, ask your healthcare provider, visit www.FinteplaREMS.com, or call 1-877-964-3649.

2. Decreased appetite and decreased weight. Decreased appetite and decreased weight are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS).

3. Sleepiness, sedation, and lack of energy (lethargy). These are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). Taking FINTEPLA with central nervous system (CNS) depressants, including alcohol, may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how FINTEPLA affects you.

4. Like all other antiepileptic drugs, FINTEPLA may cause suicidal thoughts or actions in a very small number of people (about 1 in 500).

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

How can I watch for early symptoms of suicidal thoughts and actions?

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

5. Do not stop taking FINTEPLA without first talking to your healthcare provider. Stopping a seizure medicine such as FINTEPLA can suddenly cause you to have seizures more often or seizures that do not stop (status epilepticus).

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not take FINTEPLA if you:

Before taking FINTEPLA, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take FINTEPLA?

What should I avoid while taking FINTEPLA?

What are the possible side effects of FINTEPLA?

FINTEPLA may cause serious side effects, including:

If you have any of these symptoms, call your healthcare provider right away.

These are not all the possible side effects of FINTEPLA. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1?800?FDA?1088.

Keep FINTEPLA and all medicines out of the reach of children.

General information about the safe and effective use of FINTEPLA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FINTEPLA for a condition for which it was not prescribed. Do not give FINTEPLA to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in FINTEPLA?
Active ingredient: fenfluramine hydrochloride
Inactive ingredients: cherry flavor, citric acid, ethylparaben, hydroxyethylcellulose, methylparaben, potassium citrate, sucralose, and water.

FINTEPLA contains no ingredient made from gluten-containing grain (wheat, barley, or rye) and contains no more than 0.1% of carbohydrates, which is from the cherry flavoring.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information on FINTEPLA.

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 9,000 people in approximately 40 countries, the company generated revenue of ?5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements
This press release may contain forward-looking statements including, without limitation, statements containing the words "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. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the 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 release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or 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 pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate 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 and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, 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 security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB 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-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.

Additionally, information contained in this document shall not constitute an 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

References

  1. Dravet C. The Core Dravet Syndrome Phenotype. Epilepsia. 2011 Apr;52 Suppl 2:3-9. 2.
  2. Dravet C. Dravet syndrome history. Dev Med Child Neurol. 2011 Apr;53 Suppl 2:1-6.
  3. Wu YW, Sullivan J, McDaniel SS, et al. Incidence of Dravet Syndrome in the US Population. Pediatrics. 2015 Nov;136(5):e1310-1315.
  4. FINTEPLA oral solution. U.S. Prescribing Information: Smyrna, GA: UCB, Inc.

FINTEPLA® is a registered trademark of the UCB Group of Companies.
©2024 UCB, Inc., Smyrna, GA 30080. All rights reserved.
US-FA-2400181


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