Pitolisant: Pediatric First Approval.

IF 3.4 3区医学 Q1 PEDIATRICS

Pediatric Drugs Pub Date : 2023-07-01 DOI:10.1007/s40272-023-00575-w

Susan J Keam

引用次数: 0

Abstract

Pitolisant (WAKIX^®), a histamine H₃ receptor antagonist/inverse agonist that has been developed by Bioprojet Pharma, is approved in the EU and USA and elsewhere for use in adults with narcolepsy with or without cataplexy. In February 2023, based on clinical data in patients aged 6 to < 18 years, pitolisant received its first approval in adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy in the EU. This article summarizes the milestones in the development of pitolisant leading to this pediatric first approval for narcolepsy with or without cataplexy.

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Pitolisant:儿科首次批准。

Pitolisant (WAKIX®)是一种由bioproject Pharma公司开发的组胺H3受体拮抗剂/逆激动剂，已在欧盟和美国及其他地区被批准用于伴有或不伴有猝厥的成人发作性睡病。2023年2月，基于6岁至18岁以下患者的临床数据，pitolisant首次在欧盟获批用于6岁以上青少年和儿童的发作性睡病伴或不伴猝厥的治疗。这篇文章总结了pitolisant发展的里程碑，导致这一儿童首次批准用于伴或不伴猝倒的发作性睡病。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pediatric Drugs PEDIATRICS-PHARMACOLOGY & PHARMACY

CiteScore

7.20

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes: -overviews of contentious or emerging issues. -comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development. -practical reviews covering optimum drug management of specific clinical situations. -systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. -Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population. -original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pediatric Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.