Seladelpar: 首次批准。

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2024-11-01 Epub Date: 2024-11-22 DOI:10.1007/s40265-024-02114-4

Sheridan M Hoy

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引用次数: 0

摘要

Seladelpar（LIVDELZI®）是一种口服delpar[即一种选择性过氧化物酶体增殖激活受体（PPAR）δ激动剂]，由吉利德科学公司开发，用于治疗原发性胆汁性胆管炎（PBC）。2024 年 8 月 14 日，根据碱性磷酸酶（ALP）的降低情况，该药在美国获得加速批准，用于与熊去氧胆酸（UDCA）联合治疗对 UDCA 反应不充分的成人 PBC，或作为单药治疗无法耐受 UDCA 的患者。该适应症的继续批准可能取决于确证研究对临床疗效的验证和描述。欧盟和英国正在对赛乐特治疗 PBC 进行监管评估。本文总结了seladelpar开发过程中的里程碑，这些里程碑促成了该药的首次批准。

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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Seladelpar: First Approval.

Seladelpar (LIVDELZI^®) is an oral delpar [i.e. a selective peroxisome proliferator-activated receptor (PPAR)δ agonist] being developed by Gilead Sciences for the treatment of primary biliary cholangitis (PBC). On 14 August 2024, based on a reduction in alkaline phosphatase (ALP), it received accelerated approval in the USA for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. A regulatory assessment for seladelpar for the treatment of PBC is underway in the EU and the UK. This article summarizes the milestones in the development of seladelpar leading to this first approval.

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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.