브뤼셀(벨기에) - 2022년 12월 1일, 오전 7시(CET): – 글로벌 바이오의약품 기업 UCB는 오늘 자사의 항경련제 포트폴리오(브리바라세탐, 펜플루라민, 라코사미드, 미다졸람 비강 스프레이) 데이터를 제76차 미국 뇌전증 학회(AES) 연례회의(테네시주 내슈빌)에서 발표할 예정이라고 발표했습니다. ), 12월 2~6일.
"UCB는 30년 넘게 간질 연구의 최전선에 있었습니다. 우리는 간질, 특히 희귀한 간질과 충족되지 않은 요구가 높은 환자에 대한 과학과 이해를 계속해서 발전시킬 수 있기를 기대합니다."라고 글로벌 뇌전증 MD PhD인 Konrad Werhahn이 말했습니다. UCB의 의료 업무. "올해 미국 뇌전증 학회 연례 회의에서 발표된 데이터는 간질 치료의 미래를 재정의하고 간질 발작의 영향을 받는 사람들을 위한 의미 있고 환자 중심의 치료 결과를 설계하려는 우리의 약속을 더욱 강화하고 있습니다."
데이터 하이라이트
AES에서 발표되는 주요 데이터에는 국소 발작이 있는 소아 및 노인을 포함한 여러 하위 집단의 브리바라세탐 효과와 내약성을 평가하는 국제 경험 연구에서 얻은 풍부한 통찰력뿐만 아니라 살아있는 사람들의 발작에 대한 펜플루라민의 효능과 안전성이 포함됩니다. Dravet 및/또는 Lennox-Gastaut 증후군과 일상적인 집행 기능을 포함한 비발작 매개변수에 미치는 영향. 회사 과학 전시회 "UCB: 간질 및 희귀 뇌전증 증후군에 대한 과학을 선도하다"(12월 5일 오전 9시~오후 12시(ET), 207 A/B, Floor 2, Music City Center)에 소개된 데이터 제시 는 담당 의료 전문가에게 UCB의 간질 연구, 실제 업데이트 및 최신 임상 데이터에 대한 토론에 참여할 수 있는 기회를 제공합니다.
실제 증거와 건강 평등의 주요 문제에 대한 심포지엄 초점
포스터 발표와 더불어 UCB는 AES에 등록된 대표자를 대상으로 두 번의 위성 심포지엄을 진행합니다.
UCB의 미국 간질 및 희귀 증후군 책임자인 Brad Chapman은 다음과 같이 말했습니다. “UCB가 간질, 희귀 간질 증후군 및 발작 구조에 대한 의약품 포트폴리오를 계속 확장함에 따라 우리는 계속해서 듣고 배우고 지역 사회와의 신뢰를 구축하는 데 최선을 다하고 있습니다. , 환자를 돌보고 솔루션을 찾는 방법을 발전시킵니다.”
포스터 발표
다음은 제76차 미국 간질 학회(AES 2022) 연례 회의에서 UCB가 후원한 포스터 발표에 대한 안내입니다.
브리바라세탐 포스터
펜플루라민 포스터
라코사미드 포스터
미다졸람 점비 스프레이 [FDA 승인 전용] 포스터
일반 간질 포스터
간질에 대하여1-3간질은 전 세계적으로 흔한 신경 질환으로 약 5천만 명에게 영향을 미칩니다.1 간질과 발작은 모든 연령층의 누구에게나 발생할 수 있으며,2 일반적으로 최소 2번의 발작을 경험한 후에(또는 위험이 높은 발작을 1회 경험한 후에 진단됩니다.) 더 많은 경우) 알려진 질병으로 인해 발생한 것이 아닙니다.3
간질의 UCB 소개
UCB는 항경련제 연구 및 개발 분야에서 30년의 경험을 바탕으로 간질 분야에서 풍부한 유산을 보유하고 있습니다. 간질 연구에 장기적인 노력을 기울이는 회사로서 우리의 목표는 충족되지 않은 의료 요구 사항을 해결하는 것입니다. 우리 과학자들은 간질과 그 치료에 대한 이해를 높이는 데 기여하게 된 것을 자랑스럽게 생각합니다. 우리는 우리의 목표를 공유하는 학술 기관, 제약 회사 및 기타 조직의 세계 최고의 과학자 및 임상의와 파트너십을 맺고 슈퍼 네트워크를 만듭니다. UCB에서는 간질 환자를 지원하겠다는 약속을 환자에게서 영감을 받고 과학을 통해 추진합니다.
UCB 소개
UCB, 브뤼셀, 벨기에(www.ucb.com)는 심각한 면역체계 질환이나 중추신경계 질환을 앓고 있는 사람들의 삶을 변화시키는 혁신적인 의약품과 솔루션의 발견 및 개발에 주력하는 글로벌 바이오제약 회사입니다. 약 40개국에 8,600명 이상의 직원을 두고 있는 UCB는 2021년에 58억 유로의 수익을 창출했습니다. UCB는 Euronext 브뤼셀(기호: UCB)에 상장되어 있습니다. 트위터에서 우리를 팔로우하세요: @UCB_news
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. strongOverdose /strongThere 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./p>
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30 ml/min). In paediatric patients weighing 50 kg or more and in adult patients with mild or moderate renal impairment, a loading dose of 200 mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution. In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the maximum dose is recommended. A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with mild to moderate hepatic impairment. Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment, a reduction of 25 % of the maximum dose should be applied. Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient. In adolescents and adults weighing 50 kg or more with mild to moderate hepatic impairment a loading dose of 200mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. Lacosamide is not recommended for use in children below the age of 4 years in the treatment of primary generalized tonic-clonic seizures and below the age of 2 years in the treatment of partial-onset seizures as there are limited data on safety and efficacy in these age groups. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. Therefore, patients should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies. Lacosamide should be used with caution in patients with underlying proarrhythmic conditions such as known cardiac conduction problems or severe cardiac diseases (e.g. myocardial ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and sodium channel blocking antiepileptic medicinal products, as well as in elderly patients. In these patients it should be considered to perform an electrocardiogram (ECG) before a lacosamide dose increase above 400mg/day and after lacosamide is titrated to steady-state. In the placebo-controlled clinical studies of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy studies and in post-marketing experience. In post-marketing experience, AV block (including second degree or higher AV block) has been reported. In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying proarrhythmic conditions. Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting). Patients should be counselled to seek immediate medical advice if these symptoms occur. Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. New onset or worsening of myoclonic seizures has been reported in both adult and paediatric patients with primary generalized tonic-clonic seizures (PGTCS), in particular during titration. In patients with more than one seizure type, the observed benefit of control for one seizure type should be weighed against any observed worsening in another seizure type. The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined. VIMPAT® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed). Vimpat Syrup contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. Vimpat syrup contains propylene glycol (E1520). VIMPAT® syrup contains 1.42 mg sodium per ml, equivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. VIMPAT® solution for infusion contains 59.8 mg sodium per vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Effects on ability to drive and use machines: Lacosamide may have minor to moderate influence on the ability to drive and use machines. Lacosamide treatment has been associated with dizziness or blurred vision. Accordingly, patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of lacosamide on their ability to perform such activities. Undesirable effects: The most frequently reported adverse reactions (≥10%) are dizziness, headache, nausea and diplopia. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. Other common adverse reactions (≥1% - <10%) are depression, confusional state, insomnia, balance disorder, myoclonic seizures, ataxia, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthesia, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, feeling drunk, injection site pain or discomfort (local adverse events associated with intravenous administration), irritation (local adverse events associated with intravenous administration), fall, and skin laceration and contusion. The use of lacosamide is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued. The safety profile of lacosamide in adjunctive therapy in paediatric patients with partial- onset seizures was consistent with the safety profile observed in adults. The additional adverse reactions observed in the paediatric population were pyrexia, nasopharyngitis, pharyngitis, decreased appetite, abnormal behaviour and lethargy. Somnolence was reported more frequently in the paediatric population (≥ 1/10) compared to the adult population (≥ 1/100 to < 1/10).Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: October 2022. https://www.ema.europa.eu/en/documents/product-information/vimpat-epar-product-information_en.pdf/p>