Resmetirom：首次批准。

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY Drugs Pub Date : 2024-06-01 Epub Date: 2024-05-21 DOI:10.1007/s40265-024-02045-0

Susan J Keam

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引用次数: 0

摘要

Resmetirom（Rezdiffra™）是一种口服甲状腺激素受体-β（THR-β）激动剂，由 Madrigal 制药公司开发，针对代谢功能障碍相关性脂肪性肝炎（MASH）[以前称为非酒精性脂肪性肝炎（NASH）]的主要潜在病因。2024 年 3 月，resmetirom 在美国获准与饮食和运动结合使用（加速批准），用于治疗患有中晚期肝纤维化（符合 F2 至 F3 期纤维化）的非肝硬化性 NASH 成人患者。Resmetirom还在欧盟接受监管审查，用于治疗MASH/NASH。本文总结了 Resmetirom 开发过程中的里程碑事件，这些事件促成了 Resmetirom 首次获批用于治疗成人 MASH/NASH 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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Resmetirom: First Approval.

Resmetirom (Rezdiffra™) is an oral thyroid hormone receptor-β (THR-β) agonist being developed by Madrigal Pharmaceuticals, Inc., to target the key underlying causes of metabolic dysfunction associated steatohepatitis (MASH) [previously known as nonalcoholic steatohepatitis (NASH)]. In March 2024, resmetirom was approved for use (under accelerated approval) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in the USA. Resmetirom is also under regulatory review in the EU for the treatment of MASH/NASH. This article summarizes the milestones in the development of resmetirom leading to this first approval for the treatment of adults with MASH/NASH.

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.

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