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Iqirvo用于原发性胆汁性胆管炎——疗效、安全性及未来方向。

Iqirvo for primary biliary cholangitis - efficacy, safety, and future directions.

作者信息

Saleem Rubaisha, Shakeel Amna, Riaz Rumaisa, Noman Farwa, Nasser Nathalie

机构信息

Internal Medicine, Dow University of Health Sciences (DUHS), Karachi, Pakistan.

Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon.

出版信息

Ann Med Surg (Lond). 2025 Mar 20;87(5):2758-2762. doi: 10.1097/MS9.0000000000003183. eCollection 2025 May.

Abstract

Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease characterized by progressive bile duct destruction, leading to cirrhosis and liver failure. Recent advancements in treatment have focused on targeting specific molecular pathways involved in the disease's pathogenesis. Iqirvo, a dual peroxisome proliferator-activated receptor alpha and delta agonist, has shown promise in addressing the unmet medical needs of PBC patients. This review examines the clinical development and efficacy of Iqirvo, which recently received accelerated approval from the U.S. Food and Drug Administration. The approval was based on data demonstrating improvements in biochemical markers associated with liver function and bile acid metabolism. We also discuss the safety profile, potential side effects, and future implications for the management of PBC. The expedited approval of Iqirvo represents a significant advancement in PBC therapy, offering new hope for patients unresponsive to existing treatments.

摘要

原发性胆汁性胆管炎(PBC)是一种慢性自身免疫性肝病,其特征是胆管进行性破坏,最终导致肝硬化和肝衰竭。近年来,治疗方面的进展主要集中在针对该疾病发病机制中特定的分子途径。Iqirvo是一种过氧化物酶体增殖物激活受体α和δ双重激动剂,已显示出有望满足PBC患者未被满足的医疗需求。本综述探讨了Iqirvo的临床开发和疗效,该药最近获得了美国食品药品监督管理局的加速批准。该批准基于相关数据,这些数据表明与肝功能和胆汁酸代谢相关的生化指标有所改善。我们还讨论了Iqirvo的安全性、潜在副作用以及对PBC治疗的未来影响。Iqirvo的加速批准代表了PBC治疗的重大进展,为对现有治疗无反应的患者带来了新希望。

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