Macitentan: Pediatric First Approval.

IF 3.4 3区医学 Q1 PEDIATRICS

Pediatric Drugs Pub Date : 2025-03-15 DOI:10.1007/s40272-025-00692-8

Susan J Keam

引用次数: 0

Abstract

Macitentan (Opsumit^®), an endothelin receptor antagonist (ERA) developed by Johnson & Johnson, is well established worldwide as monotherapy or combination therapy for the long-term treatment of pulmonary arterial hypertension (PAH). In September 2024, based on phase 3 clinical data in patients aged < 18 years, macitentan received its first pediatric approval in the EU as monotherapy or in combination for the long-term treatment of PAH in pediatric patients aged 2 years to < 18 years with WHO functional class (FC) II to III. Macitentan has also been approved in the UK for this indication. This article summarizes the milestones in the development of macitentan leading to the first pediatric approval for the long-term treatment of PAH.

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马替坦：儿科首次批准。

Macitentan （Opsumit®）是由强生公司开发的内皮素受体拮抗剂（ERA），在全球范围内被广泛应用于肺动脉高压（PAH）的单药或联合治疗。2024年9月，基于3期临床数据的老年患者

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

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