US FDA approves expanded indication for UCB’s Briviact to treat paediatric patients

美国FDA批准UCB Briviact扩大适应症治疗儿科患者

2021-08-31 22:30:17 PHARMACEUTICAL

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The US Food and Drug Administration has approved an expanded indication for UCB’s Briviact CV as monotherapy or adjunctive therapy for the treatment of partial-onset seizures in paediatric patients aged one month and above. In 2016, the drug was approved in the US as an add-on therapy for adult patients and was also approved as monotherapy for adults in September 2017. Briviact was approved as monotherapy or adjunctive therapy to treat partial-onset seizures in patients aged four years and above in 2018. It is available in three formulations including oral tablets, oral solution, and intravenous (IV) injection. UCB claimed that it is the only IV formulation FDA-approved for the treatment of partial-onset seizures for children in nearly seven years. UCLA Mattel Children’s Hospital and UCLA David Geffen School of Medicine Rubin Brown Endowed Chair Pediatric Neurology chief and distinguished professor Raman Sankar said: “We often see children with seizures hospitalized, so it’s important to have a therapy like BRIVIACT IV that can offer rapid administration in an effective dose when needed and does not require titration. The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home. “Now that Briviact IV and oral formulations are an approved therapy for partial-onset seizures in children as young as one month, we have a new option that helps meet a critical need in pediatric epilepsy.” It was found that around 71.4% and 64.3% of patients aged one month and above 17 years with partial-onset seizures remained on treatment with Briviact for one and two years in open-label paediatric trials. The most common adverse reactions found in patients using Briviact include somnolence and sedation, dizziness, fatigue, nausea and vomiting symptoms.
美国食品药品监督管理局(FDA)已批准UCB的Briviact(brivaracetam)CV作为单一疗法或辅助疗法,用于治疗一个月及以上儿童部分发作性癫痫的扩大适应症。 2016年,该药在美国获批作为成人患者的附加疗法,2017年9月又获批作为成人单药疗法。 2018年,Briviact被批准作为单一疗法或辅助疗法,用于治疗四岁及以上患者的部分发作性癫痫。 它有三种剂型,包括口服片剂、口服溶液和静脉注射(IV)。 UCB声称,这是近七年来唯一一种FDA批准的用于治疗儿童部分发作性癫痫的静脉注射制剂。 加州大学洛杉矶分校美泰儿童医院和加州大学洛杉矶分校大卫·格芬医学院鲁宾·布朗教授儿科神经病学主任兼杰出教授拉曼·桑卡尔说:“我们经常看到癫痫发作的儿童住院,所以像BRIVIACT IV这样的疗法很重要,它可以在需要时提供有效剂量的快速给药,而且不需要滴定。当这些年轻患者从医院过渡到家庭时,口服剂量形式的可用性也允许治疗的连续性。 “现在Briviact IV和口服制剂是一种批准的治疗一个月大的儿童部分发作性癫痫的疗法,我们有了一种新的选择,可以帮助满足儿科癫痫的关键需求。” 在开放标签的儿科试验中发现,大约71.4%和64.3%的1个月和17岁以上的部分发作性癫痫患者仍然接受Briviact治疗1年和2年。 在使用Briviact的患者中发现的最常见的不良反应包括嗜睡和镇静、头晕、疲劳、恶心和呕吐症状。

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