预约演示
UCB presents late-breaking posters at Child Neurology Society Meeting
2023-10-04
上市批准临床结果临床研究
ATLANTA, Oct. 4, 2023 /PRNewswire/ -- The Child Neurology Society Meeting, a prominent event in the field of pediatric neurology, is set to showcase cutting-edge research and developments in child neurology. As part of this conference, UCB will present two late-breaking posters that shed light on the care and management of Dravet syndrome.
Poster 1:
Outcomes Among Individuals With Dravet Syndrome Using Fenfluramine: A Retrospective Analysis Using U.S. Claims Data
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Fintepla® (fenfluramine) 2.2 mg/mL oral solution)
Finteplayndfenfluramine and severe developmental epileptic encephalopathy, has long presented challenges in terms of treatment and care. However, a new retrospective analysis utilizing U.S. claims data has unveiled promising outcomes for individuals with Dravet syndrome who were treated with fenfluramine, following its approval in June 2020 for the management of seizures associated with Dravet syndrome in the United States.1
Dravet syndromef this analysis was developmental epileptic encephalopathyenfluramine and seizure-related healthcare events through claims data. The study utilized the Komodo U.S. healthcare claims database to measure healthcare utilization, including rescDravet syndrome medication use and heafenfluraminets. Individuals with Dravet syndrome were identified by ICD-seizures. Patients receivDravet syndromemitant cannabidiol or stiripentol were excluded.1
Among the 108 individuals with Dravet syndrome included in the analysis,fenfluramineals (seizured continuous fenfluramine use for a minimum of 6 months. This subset exhibited a 77% reduction in rescue antiseizure medication use (P1seizureDravet syndromecannabidiolstiripentol
The findings suggest that meaniDravet syndromes in healthcare utilization were observed among individuals witfenfluraminedrome treated with fenfluramine for at least 6 months. The 6-month persistency rate of fenfluramine usage indicates not only its efficacy but also its tolerability in this patient population.1
Authors: Srihari Jaganathan, Derek Ems, Rob Sederman, Chen Chen, Shuang WuDravet syndromefenfluraminefenfluramine
Poster 2: Diagnosis and Information Management of Dravet Syndrome in Recently Diagnosed Pediatric Patients: Results From a Dravet Syndrome Foundation Caregiver Insight Survey
The second late-breaking poster explored the challDravet Syndromeng the early diagnosis of Dravet syndrome. Caregivers of pDravet Syndromets aged ≤4 years, diagnosed with Dravet syndrome, were surveyed to gather insights into their experiences.2
The survey, distributed via the Dravet Syndrome Foundation Family Network, received responsDravet syndromegivers. The results highlighted that the average age at symptom oDravet syndromehs, while the average age at Dravet syndrome diagnosis was 12 months. Changes in healthcare providers were common, with the most frequent reasons being clinical expertise and trust. The poster further highlights the vital role that patient advocacy groups and online resources play in providing caregivers with valuable information and support during the diagnosis and management process.2
Authors: Andrea Wilkinson, BA, DDravet Syndrome Foundation Family Networknne Meskis, Laurie Bailey, BCPA, Rebecca Burns, PharmD, PhD, Amélie Lothe, PhDDravet syndrome
These posters underscore the advancements in understanding and managing Dravet syndrome, as well as the pivotal role of both medical interventions and patient advocacy resources in enhancing the lives of those affected by this condition.1,2
About FINTEPLA® (fenfluramine)1Dravet syndrome
In theFINTEPLAIN(fenfluramine)1ed 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 aFINTEPLA in the U.S. through the FINTEPLA seizuresluation and MitigDravet syndrome (DS)). FuLennox-Gastaut syndrome (LGS)e at www.FinteplaREMS.com or by telephone at 1-877-964-3649.
FINTEPLAee full Prescribing Information, including Boxed Warning, for additional important information on FINTEPLA.
INDICATIONFINTEPLA
FINTEPLA is a prescription medicine used to treat seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.
FINTEPLAt known if FINTEPLA is safe and effective seizuresren less than 2 yDravet syndromeLennox-Gastaut syndrome
IMPORTANT SAFETY INFINTEPLAN
FINTEPLA can cause serious side effects, including:
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 awavalvular heart diseasef these signs and symptoms of heart or lung problems durpulmonary arterial hypertensionfenfluramineFINTEPLAFINTEPLAFINTEPLA
shortness of breathFINTEPLA
chest pain
chest painor weakness, especially with increased activity
lightheadedness or fainting
irregular pulse
swollen ankles or feet
bluish color of your lips and skin (cyanosis)
Because of the risk of heart valve problems (valvular heart disease) and high blood pressure in arteries of lungs (pulmonary arterial hypertension), FINTEPLA is only available through a restricted program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS). 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.
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).
Your weight should be checked regularly during your treatment with FINTEPLA.FINTEPLADravet syndrome (DS)Lennox-Gastaut syndrome (LGS)
Your healthcare provider may need to make changes to your FINTEPLA FINTEPLAyour weight decreases. In some cases, FINTEPLA may need to be stopped.
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.
Sleepinessvesedatione heavy machinery, or do other dangerous activities until you know how FINTEPLA affFINTEPLA.Dravet syndrome (DS)Lennox-Gastaut syndrome (LGS)FINTEPLAalcoholsleepiness
4.FINTEPLA
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 healtantiepileptic drugst FINTEPLAyou have any of these symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
new or worse anxiety
trouble sleepanxietysomnia)
acting on dangerouinsomniaes
attempts to commit suicide
feeling agitated or restless
other unusual changes in behavior or mood
new or worse irritability
an extreme inirritabilitytivity and talking (mania)
new or worse depression
panic attacksdepression
acting aggressive, being angry or violent
How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
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).
Do not take FINTEPLA if you:
are allergicFINTEPLAluramine or any of the ingredients in FINTEPLA. See below for a complete list of ingredients in FINTEPLA.
are taking or hafenfluramineaking medicines called monoamiFINTEPLAse inhibitors (MAOIs) in the last 14 days. This maFINTEPLAa serious or life-threatening problem called
serotonin
syndrome. If you are not sure whether or not you are taking one of these medicines, contact your healthcare provider.
Before taking FINTEPLA, tell your healthcare provider about all of your medical conditions, including if you:
have heart proFINTEPLA
have or have had weight loss
have or have had depression, mood problems, or suicidal thoughts or behavior
have kidney probldepression
have liver problems
are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking FINTEPLA. You and your healthcare provider will decide if you should take FINTEPLA while you are pregnant.
If you become pregnant while taking FINTEPLA, talk to your healthcare provider about registering with the North AmericFINTEPLApileptic Drug Pregnancy Registry. You can enroll in this registry FINTEPLAng 1-888-233-2334 or go to www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
are breastfeeding or plan to breastfFINTEPLAis not known if FINTEPLA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking FINTEPLA.antiepileptic drugs
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?
Read theFINTEPLA
Instructions for Use for information on the right way to use FINTEPLA.
Take FINTEPLA exactly as your healthcare provider tells you tFINTEPLAt.
Your FINTEPLAre provider will tell you how much FINTEPLA to take and when to take it.
FINTEPLA may be taken with or without food.FINTEPLA
FINTEPLAyour dose of FINTEPLA using the dosing syringe that is provided by the pharmacy. Do not use a household teaspoon or tablespoon.
FINTEPLA can be givenFINTEPLA gastric and nasogastric feeding tubes.
FINTEPLAuld I avoid while taking FINTEPLA?
Do not drive, operate heavy machiFINTEPLA do other dangerous activities until you know how FINTEPLA affects you. FINTEPLA may cause you to feel sleepy.
FINTEPLA may cause serious side effectFINTEPLAding:
FINTEPLA can cause serious side effects" above
FINTEPLAn syndrome. Serotonin syndrome is a life-threatening problem that can happen in people taking FINTEPLA, especially if FINTEPLA is taken with certain other medicines including: anti-depressant medicines called SSRIs, SNRIs, TCAs, and MAOIs; tryptophan; lithium; antipsychotics; St. John's Wort; dextromethorphan; tramadol.
Call your healthcareSerotonin syndromeay if you have any of the following symptoms of serotonin syndroFINTEPLAFINTEPLAtryptophanlithiumdextromethorphantramadol
mental status changes such as seeing things that are not there (hallucinations), agitaserotonin syndrome
changes in blood pressurehallucinationsagitationcoma
tight muscles
fast heartbeat
nausea, vomiting, diarrhea
trouble walking
High blood pressure (hypertension). Hypertension is both a serious and common side effect. FINTEPLA can cause your blood pressure to increase even if you have never had high blood pressure before. Your healthcare provider will check your blood pressure while you are taking FINTEPLA.
Increased pressure inhypertensionglaHypertensiontoms of glaucoma may include:FINTEPLAFINTEPLA
seeing halos or bright colors around lights
nausea or vomiting
eye pain or discomfort
eye painvision
If you have any of these symptoms, call your healthcare provider right away.
The most common side effects of FINTEPLA when used to treat Dravet syndrome (DS) include:
decreased appetiteFINTEPLADravet syndrome (DS)
diarrhea
diarrheagy
respiratory infection
decreased weight
fever
feveripation
abnormal echocardiogram
sleepiness
problems with movement, balance, and walking
increased drooling
increased blood pressure
vomiting
falls
seizures that do not stop
The most common side effects of FINTEPLA when used to treat
Lennox-Gastaut syndrome (LGS) inFINTEPLA
diarrhea
vomiting
sleepiness
decreased appetite
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 FINTEPLA You may report side effects to the FDA at 1–800–FDA–1088.
Keep FINTEPLA and all medicines out of the reach of children.FDA
General information about the safe and effective use of FINTEPLA.
Medicines are sometimes prescribed for purposes other thFINTEPLA 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.
Active ingredient: fenfluramFINTEPLAochloride
Inactive ingredientfenfluramineavor, citric acid, ethylparaben, hydroxyethylcellulose, methylparaben, potassium citrate, sucralose, and water.
FINTEPLA contains no ingredient made from gluten-containing graihydroxyethylcelluloserye) and containspotassium citrate1% of carbohydrates, which is from the cherry flavoring.
FINTEPLAee full Prescribing Information, including Medication Guide, for additional Important Safety Information on FINTEPLA.
For further information, contact UCB:FINTEPLA
Corporate CommunicationsUCB
Becky Malone, U.S. Media Relations
T +919.605.9600
[email protected]
Investor Relations
Antje Witte
T +32.2.559.9414
[email protected]
About UCB
UCB, BUCBsels, 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 € 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
_______________________________________
1. Srihari Jaganathan, Derek Ems, Rob Sederman, Chen Chen, Shuang Wu; Outcomes Among Individuals with Dravet Syndrome Using Fenfluramine: A Retrospective Analysis Using U.S. Claims Data
2. Andrea Wilkinson, BA, Danya Kaye, BA, Veronica Hood, Ph.D., Mary Anne Meskis, Laurie Bailey, BCPA, Dravet SyndromePharmD,Fenfluramineie Lothe, Ph.D.; Diagnosis and Information Management of Dravet Syndrome in Recently Diagnosed Pediatric Patients: Results from a Dravet Syndrome Foundation Caregiver Insight Survey
FINTEPLA® is a registered trademark of the UCB Group of Companies.Dravet Syndrome
FINTEPLAB, Inc., Smyrna, GA 30080. All righUCB Group of CompaniesS-2300472
SOURCEUCB, Inc.
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