Brussels, Belgium – 27th June 2025 – 07:00 CET

比利时布鲁塞尔 – 2025年6月27日 – 欧洲中部时间07:00

– UCB, a global biopharmaceutical company, today announced that the phase 3 study investigating the safety and efficacy of adjunctive fenfluramine in CDKL5 Deficiency Disorder (CDD) met its primary and key secondary endpoints.

优时比（UCB），一家全球生物制药公司，今天宣布，评估辅助性芬氟拉明在CDKL5缺陷症（CDD）中的安全性和有效性的3期研究达到了其主要和关键次要终点。

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The study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center study examining the efficacy, safety, and pharmacokinetics of adjunctive fenfluramine treatment in 87 children and adults aged 1 – 35, with a CDD diagnosis and uncontrolled seizures.

该研究是一项随机、双盲、安慰剂对照、固定剂量、多中心研究，评估了87名1至35岁患有CDD诊断且癫痫发作未受控制的儿童和成人使用辅助芬氟拉明治疗的疗效、安全性和药代动力学。

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'These results pave the way for creating significant therapeutic progress and represent an important milestone in UCB’s mission to bring meaningful innovation to individuals and families affected by developmental and epileptic encephalopathies (DEEs). We are grateful to the patients, families, and researchers who made this progress possible, and we look forward to working with the health authorities to make treatment available as soon as possible”, said Fiona du Monceau, Executive Vice President, Patient Evidence, UCB..

“这些结果为创造重要的治疗进展铺平了道路，并标志着优时比 (UCB) 在为受发育性和癫痫性脑病 (DEEs) 影响的个人和家庭带来有意义创新的使命中迈出了重要一步。我们感谢那些使这一进展成为可能的患者、家属和研究人员，并期待与卫生部门合作，尽快让治疗方案落地”，优时比 (UCB) 执行副总裁、患者证据部门负责人 Fiona du Monceau 表示。

CDD is an ultra-rare DEE with refractory infantile-onset epilepsy and severe global neurodevelopmental delays resulting in intellectual, motor, cortical visual, and sleep impairments as major features.

CDD是一种超罕见的DEE，具有难治性婴儿期癫痫发作和严重的全面神经发育迟缓，导致智力、运动、皮质视觉和睡眠障碍为主要特征。

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It is caused by pathogenic variants in the Cyclin Dependent Kinase-like 5 (CDKL5) gene located on the X chromosome. It is estimated that CDD affects approximately 1 in 40,000 to 60,000 live births, with a median age of onset of six weeks.

它是由位于X染色体上的细胞周期蛋白依赖性激酶样5（CDKL5）基因的致病变异引起的。据估计，CDD影响大约每40,000到60,000名活产婴儿中的1人，发病的中位年龄为六周。

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The primary endpoint of the study is based on the median percent change in countable motor seizure frequency (CMSF) between baseline and the titration plus maintenance phase, comparing fenfluramine with the placebo group.

该研究的主要终点是基于可计数的运动性癫痫发作频率（CMSF）在基线与滴定加维持阶段之间的中位百分比变化，比较芬氟拉明与安慰剂组的差异。

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Full results will be presented at an upcoming scientific congress.

完整结果将在即将召开的科学大会上公布。

In the study, fenfluramine was generally well-tolerated, and the safety profile was consistent with previous studies on DS/LGS.

在研究中，芬氟拉明一般耐受性良好，其安全性与之前对DS/LGS的研究一致。

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UCB is currently conducting an open-label, flexible-dose, long-term 52-week extension phase of the study to characterize the long-term safety and tolerability of fenfluramine in pediatric and adult individuals with CDD.

UCB目前正在进行一项开放标签、灵活剂量、为期52周的长期延长期研究，以评估芬氟拉明在患有CDD的儿童和成人中的长期安全性和耐受性。

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In the European Union (EU), fenfluramine is approved 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.

在欧盟 (EU)，芬氟拉明被批准用于治疗与Dravet综合征和Lennox-Gastaut综合征相关的癫痫发作，作为2岁及以上患者其他抗癫痫药物的辅助疗法。

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In the United States, fenfluramine oral solution is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.

在美国，芬氟拉明口服溶液适用于治疗2岁及以上患者与Dravet综合征和Lennox-Gastaut综合征相关的癫痫发作。

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It is not approved for use in CDD by any regulatory authority worldwide.

它未获得世界上任何监管机构批准用于CDD。

For further information, contact UCB:

如需更多信息，请联系UCB：

Global Communications

全球通讯

Anna Clark

安娜·克拉克

T: +44.73.8.668.67.79

电话：+44.73.8.668.67.79

Anna.clark@ucb.comm

安娜.克拉克@ucb.comm

Corporate Communications, Media Relations

企业传播、媒体关系

Laurent Schots

劳伦特·肖茨

T +32.2.559.92.64

电话：+32.2.559.92.64

Laurent.schots@ucb.com

Laurent.schots@ucb.com

Investor Relations

投资者关系

Antje Witte

安特耶·维特

T +32.2.559.94.14

电话：+32.2.559.94.14

antje.witte@ucb.com

antje.witte@ucb.com

Sahar Yazdian

叶海亚·萨哈ർ

T +32.2.559.91.37

电话：+32.2.559.91.37

sahar.yazdian@ucb.com

sahar.yazdian@ucb.com

About UCB

关于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 € 6.15 billion in 2024.

优时比公司（UCB），位于比利时布鲁塞尔（www.ucb.com），是一家全球生物制药公司，专注于发现和开发创新药物和解决方案，以改变免疫系统或中枢神经系统严重疾病患者的生活。该公司在约40个国家拥有大约9,000名员工，并在2024年创造了61.5亿欧元的收入。

UCB is listed on Euronext Brussels (symbol: UCB).  .

UCB在布鲁塞尔泛欧交易所上市（股票代码：UCB）。

UCB Forward Looking Statement

UCB前瞻性声明

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.

本文件包含前瞻性陈述，包括但不限于包含“潜在”、“相信”、“预期”、“预计”、“打算”、“计划”、“寻求”、“估计”、“可能”、“将”、“继续”等词语及类似表达的陈述。这些前瞻性陈述基于管理层当前的计划、估计和信念。

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.

所有声明，除历史事实声明外，均可能被视为前瞻性声明，包括收入、营业利润率、资本支出、现金、其他财务信息、预期的法律、仲裁、政治、监管或临床结果或实践以及其他此类估计和结果。

By their nature, such forward-looking statements are not guaranteeing 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 be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. .

由于此类前瞻性陈述的性质，其并不保证未来的表现，并且受到已知和未知的风险、不确定性以及假设的影响，这些因素可能导致UCB的实际结果、财务状况、业绩或成就，或行业结果，与本文件中包含的此类前瞻性陈述所明示或暗示的任何未来结果、业绩或成就存在重大差异。

Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, 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, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB’s information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees.

可能导致此类差异的重要因素包括但不限于：战争、疫情和恐怖主义的全球传播及其影响、总体地缘政治环境、气候变化、总体经济、商业和竞争状况的变化、无法获得必要的监管批准或未能在可接受的条件或预期时间内获得批准、与研发相关的成本、UCB在研产品或开发中产品的前景变化、未来司法裁决或政府调查的影响、安全性、质量、数据完整性或生产问题、供应链中断和业务连续性风险；潜在或实际的数据安全和隐私泄露，或UCB信息技术系统的中断、产品责任索赔、针对产品或候选产品的专利保护挑战、来自其他产品（包括生物类似药或颠覆性技术/商业模式）的竞争、法律法规的变化、汇率波动、与税收和关税相关法律和/或规则及其执行的变更或不确定性，以及员工的招聘、留任和合规问题。

There is no guarantee that new product candidates will be discovered or identified in the pipeline, 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.

无法保证在研发管线中会发现或识别出新的产品候选者，也无法保证现有产品的新的适应症能够被开发并获得批准。从概念到商业产品的推进过程充满不确定性；临床前结果不能保证产品候选者在人体中的安全性和有效性。

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.

到目前为止，人体的复杂性无法在计算机模型、细胞培养系统或动物模型中重现。完成临床试验和获得产品上市监管批准的时间长度已经。

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.

鉴于这些不确定性，公众被提醒不要对这些前瞻性声明给予任何过度依赖。这些前瞻性声明仅在本文件发布之日作出，并不反映上述不断演变的事件或风险以及任何其他不利因素的潜在影响，除非另有说明。

The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB..

公司继续认真跟进事态的发展，以评估这些事件对UCB的财务重要性（如有）。

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..

UCB明确表示，除非适用法律法规要求，否则不对更新本文件中的任何前瞻性声明承担任何义务，无论这是为了确认实际结果，还是为了报告或反映与其前瞻性声明相关的任何变化，或任何此类声明所基于的事件、条件或情况的任何变化。

Important Safety Information about FINTEPLA

关于FINTEPLA的重要安全信息

®

®

▼ (fenfluramine) in the EU

▼ （芬氟拉明）在欧盟

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Indications:

适应症：

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.

用于治疗与Dravet综合征和Lennox-Gastaut综合征相关的癫痫发作，作为2岁及以上患者其他抗癫痫药物的辅助疗法。

Dosage and Administration

剂量与用法

: Please refer to SmPC for full information. Should be initiated and supervised by physicians with experience in the treatment of epilepsy. Fintepla is prescribed and dispensed according to the Fintepla controlled access programme. Dravet syndrome: Patients who are not taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day).

：有关完整信息，请参阅SmPC。应由有癫痫治疗经验的医生启动和监督。Fintepla根据Fintepla管控获取计划进行处方和分发。Dravet综合征：未服用stiripentol的患者：起始剂量为0.1 mg/kg，每日两次（0.2 mg/kg/天）。

After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day). After an additional 7 days, if tolerated and further seizure reduction required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose. Patients requiring more rapid titration may increase the dose every 4 days.

7天后，如果耐受，可将剂量增加至每日两次0.2 mg/kg（每日0.4 mg/kg）。再过7天后，如果耐受且需要进一步减少癫痫发作，可将剂量增加至最大值每日两次0.35 mg/kg（每日0.7 mg/kg），这是推荐的维持剂量。需要更快速滴定的患者可以每4天增加一次剂量。

Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day), which is the recommended maintenance dose. Patients requiring more rapid titration may increase the dose every 4 days.

每日剂量不得超过26毫克（每次13毫克，每日两次）。正在服用司替戊醇的患者：起始剂量为每日两次0.1毫克/千克（每日0.2毫克/千克）。7天后，如果耐受良好，可将剂量增加至每日两次0.2毫克/千克（每日0.4毫克/千克），这是推荐的维持剂量。需要更快速滴定的患者可以每4天增加一次剂量。

Do not exceed a total dose of 17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increased to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated. After an additional 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose.

总剂量不应超过17毫克（8.6毫克，每日两次）。Lennox-Gastaut综合征：起始剂量为0.1毫克/公斤，每日两次（0.2毫克/公斤/天）。如果耐受良好，7天后剂量应增加至0.2毫克/公斤，每日两次（0.4毫克/公斤/天）。再过7天后，如果耐受良好，剂量应增加至0.35毫克/公斤，每日两次（0.7毫克/公斤/天），这是推荐的维持剂量。

Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When discontinuing treatment, decrease the dose gradually. As with all anti-epileptic medicines, avoid abrupt discontinuation when possible to minimize the risk of increased seizure frequency and status epilepticus. A final echocardiogram should be conducted.

每日最大剂量不应超过26毫克（每次13毫克，每日两次）。停药：停药时应逐渐减少剂量。与所有抗癫痫药物一样，尽量避免突然停药，以减少癫痫发作频率增加和癫痫持续状态的风险。应进行最终的超声心动图检查。

Contraindications

禁忌症

: Hypersensitivity to active substance or any excipients. Aortic or mitral valvular heart disease and pulmonary arterial hypertension. Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome.

对活性物质或任何辅料过敏者禁用。主动脉或二尖瓣心脏病和肺动脉高压患者禁用。在使用单胺氧化酶抑制剂的14天内，由于血清素综合征的风险增加，应避免使用。

Warnings and Precautions

警告和注意事项

: Aortic or mitral valvular heart disease and pulmonary arterial hypertension: Prior to starting treatment, patients must undergo an echocardiogram to establish a baseline and exclude any pre-existing valvular heart disease or pulmonary hypertension. Conduct echocardiogram monitoring every 6 months for the first 2 years and annually thereafter.

主动脉或二尖瓣瓣膜性心脏病和肺动脉高压：在开始治疗前，患者必须接受超声心动图检查，以建立基线并排除任何已有的瓣膜性心脏病或肺动脉高压。在治疗的前2年，每6个月进行一次超声心动图监测，此后每年一次。

If an echocardiogram indicates pathological valvular changes, consider follow-up earlier to evaluate whether the abnormality is persistent. If pathological abnormalities seen on echocardiogram, evaluate the benefit versus risk of continuing fenfluramine treatment with the prescriber, caregiver and cardiologist.

如果超声心动图显示病理性瓣膜变化，应考虑提前随访，以评估异常是否持续存在。如果超声心动图上发现病理性异常，应与处方医生、护理人员和心脏病专家一起评估继续使用芬氟拉明治疗的益处与风险。

Once treatment is discontinued for any reasons, a final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. If echocardiogram findings suggestive of pulmonary arterial hypertension, perform a repeat echocardiogram as soon as possible and within 3 months to confirm these findings.

一旦因任何原因停止治疗，应在最后一次服用芬氟拉明后3-6个月内进行最终的超声心动图检查。如果超声心动图结果显示可能存在肺动脉高压，应尽快并在3个月内重复进行超声心动图以确认这些结果。

If echocardiogram finding is confirmed suggestive of an increased probability of pulmonary arterial hypertension defined as intermediate probability, conduct a benefit-risk evaluation of continuation of Fintepla by the prescriber, carer and cardiologist. If echocardiogram suggests a high probability, it is recommended fenfluramine treatment should be stopped.

如果超声心动图检查结果确认提示肺动脉高压的中等概率，开具者、护理人员和心脏病专家应进行芬特卡尼（Fintepla）继续使用的风险效益评估。如果超声心动图提示高概率，建议停止芬氟拉明（fenfluramine）治疗。

Decreased appetite and weight loss: Fenfluramine can cause decreased appetite and weight loss - an additive effect can occur in combination with other anti-epileptic medicines such as stiripentol. Monitor the patient’s weight. Undertake risk-benefit evaluation before starting treatment if history of anorexia nervosa or bulimia nervosa.

食欲减退和体重减轻：芬氟拉明可导致食欲减退和体重减轻——与其它抗癫痫药物（如司替戊醇）合用时可能会产生叠加效应。监测患者的体重。如果患者有神经性厌食症或神经性贪食症病史，在开始治疗前应进行风险-收益评估。

Fintepla controlled access programme: A controlled access programme has been created to 1) prevent off-label use .

Fintepla管控访问计划：已创建一个管控访问计划以1）防止标签外使用。

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 ocular pain of unknown origin. Effect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 inducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations, which may lower the efficacy of fenfluramine.

疗效可能会降低。青光眼：芬氟拉明可引起瞳孔散大，并可能诱发闭角型青光眼。若患者视力急性下降，应停止治疗。若出现不明原因的眼痛，考虑停药。CYP1A2或CYP2B6诱导剂的影响：与强效CYP1A2诱导剂或CYP2B6诱导剂联合使用会降低芬氟拉明的血浆浓度，这可能会降低芬氟拉明的疗效。

If co-administration 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.

如果认为共同给药是必要的，应监测患者是否出现疗效降低，并且在不超过两倍的情况下可以考虑增加芬氟拉明的剂量。

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.

最大日剂量（52毫克/天）。如果在使用芬氟拉明维持治疗期间停用强效CYP1A2或CYP2B6诱导剂，应考虑逐步减少芬氟拉明的剂量至诱导剂开始前的剂量。CYP1A2或CYP2D6抑制剂的影响：与强效CYP1A2或CYP2D6抑制剂同时开始治疗可能导致更高的暴露量，因此应监测不良事件，并且部分患者可能需要减少剂量。

Excipients: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl para-hydroxybenzoate (E 219) - may cause allergic reactions.

辅料：含乙基对羟基苯甲酸钠（E 215）和甲基对羟基苯甲酸钠（E 219）——可能引起过敏反应。

(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 medicine. The product contains less than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially ‘sodium-free’.

（可能有延迟）。它还含有二氧化硫 (E 220)，这可能会极少数情况下引起严重的过敏反应和支气管痉挛。患有罕见的葡萄糖-半乳糖吸收不良的患者不应服用此药。该产品在每日最大剂量12毫升中含钠量少于1毫摩尔（23毫克），基本上属于“无钠”。

Contains glucose - may be harmful to teeth. Interactions: Pharmacodynamic interactions with other CNS depressants increase the risk of aggravated central nervous system depression. An.

含有葡萄糖——可能对牙齿有害。相互作用：与其他中枢神经系统抑制剂的药效学相互作用会增加中枢神经系统抑制加重的风险。

increase in dose may be necessary when coadministered with rifampicin or a strong CYP1A2 or CYP2B6 inducer. In in vitro studies coadministration with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 of the SmPC). Coadministration with CYP2D6 substrates or MATE1 substrates may increase their plasma concentrations.

与利福平或强效CYP1A2或CYP2B6诱导剂联合使用时，可能需要增加剂量。在体外研究中，与强效CYP1A2或CYP2D6抑制剂联合使用可能导致更高的暴露量（见SmPC第4.4节）。与CYP2D6底物或MATE1底物联合使用可能增加其血浆浓度。

Co-administration with CYP2B6 or CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and lactation: Limited data in pregnant women. As a precaution, avoid use of Fintepla in pregnancy. It is unknown whether fenfluramine/metabolites are excreted in human milk. Animal.

与CYP2B6或CYP3A4底物共同给药可能会降低其血浆浓度。妊娠与哺乳：孕妇中的数据有限。作为预防措施，避免在妊娠期间使用Fintepla。目前尚不清楚芬氟拉明/代谢物是否排泄到人乳中。动物。

data have shown excretion of fenfluramine/metabolites in milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fintepla taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Drive and use machines.: Fintepla has moderate influence on the ability to drive/ use machines as it may cause somnolence and fatigue.

数据显示芬氟拉明/代谢物会排泄到乳汁中。必须权衡母乳喂养对婴儿的益处和该药物对女性治疗的益处，以决定是否停止哺乳或停止/避免使用芬特普拉。驾驶和操作机器：芬特普拉对驾驶/操作机器的能力有中度影响，因为它可能引起嗜睡和疲劳。

Advise patients not to drive or operate machinery until they have sufficient experience to gauge whether it adversely.

建议患者在没有足够经验判断是否会产生不良影响之前，不要驾驶或操作机器。

affects their abilities.

影响他们的能力。

Adverse effects

不良反应

: Dravet syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of trace and mild mitral regurgitation, and trace aortic regurgitation, which are considered physiologic).

Dravet综合征：非常常见（≥1/10）：上呼吸道感染、食欲减退、嗜睡、腹泻、发热、疲劳、血糖降低、超声心动图异常（包括微量和轻度二尖瓣反流以及微量主动脉瓣反流，这些均被认为是生理性的）。

Common (≥1/100 to <1/10): Bronchitis, abnormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypotonia, lethargy, seizure, status epilepticus, tremor, constipation, salivary hypersecretion, weight decreased and blood prolactin increased. Lennox-Gastaut syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fatigue.

常见（≥1/100 至 <1/10）：支气管炎、异常行为、攻击性、激惹、失眠、情绪波动、共济失调、肌张力低下、嗜睡、癫痫发作、癫痫持续状态、震颤、便秘、唾液分泌过多、体重减轻和血液催乳素升高。Lennox-Gastaut 综合征：很常见（≥1/10）：上呼吸道感染、食欲下降、嗜睡、腹泻、呕吐、疲劳。

Common (≥1/100 to <1/10): Bronchitis, influenza, pneumonia, seizure, status epilepticus, lethargy, tremor, constipation, salivary hypersecretion, blood prolactin increased, weight decreased, fall. Refer to SmPC for other adverse reactions. .

常见（≥1/100 至 <1/10）：支气管炎、流感、肺炎、癫痫发作、癫痫持续状态、嗜睡、震颤、便秘、唾液分泌过多、血泌乳素升高、体重减轻、跌倒。其他不良反应请参阅 SmPC。

▼

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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.

该药品受到额外的监测。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。

Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information.

请参阅欧洲产品特性摘要以获取其他不良反应和完整的处方信息。

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf (accessed October 2024)

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf （访问于2024年10月）

References:

参考文献：

UCB data on file. 2025

UCB数据存档。2025

ClinicalTrials.gov. NCT05064878. Available at:

ClinicalTrials.gov. NCT05064878. 可在：

https://clinicaltrials.gov/study/NCT05064878

https://clinicaltrials.gov/study/NCT05064878

. Accessed: June 2025.

访问日期：2025年6月。

Overview of Medical-scientific Research in the Netherlands (OMON). A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Examine the Efficacy and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder Followed by an Open-Label Extension. 2022. Available at:

荷兰医学科学研究概况 (OMON)。一项三期、随机、双盲、安慰剂对照、固定剂量、多中心研究，以检查ZX008在CDKL5缺乏症患者中的有效性和安全性，并随后进行开放标签扩展研究。2022年。可访问于：

https://onderzoekmetmensen.nl/en/node/56446/pdf

https://onderzoekmetmensen.nl/en/node/56446/pdf

. Accessed: June 2025.

访问日期：2025年6月。

Zuberi et al. ILAE classification and definition of epilepsy syndromes with onset in neonates and infants: Position statement by the ILAE Task Force on Nosology and Definitions. Epilepsia.2022;63(6):1349-97.

祖贝里等。国际抗癫痫联盟（ILAE）关于新生儿和婴儿期发病的癫痫综合征的分类与定义：ILAE命名和定义工作组的立场声明。《癫痫》。2022；63（6）：1349-97。

Fintepla

芬特普利

®

®

EU SmPC.

欧盟药品特性摘要。

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

. Accessed June 2025.

。访问时间：2025年6月。

Fintepla

芬特普利

®

®

US PI.

美国私家侦探。

https://www.ucb-usa.com/fintepla-prescribing-information.pdf

https://www.ucb-usa.com/fintepla-prescribing-information.pdf

. Accessed June 2025.

访问时间：2025年6月。