Latest FDA approved drug Elafibranor (Iqirvo): a novel prospect for treatment of primary biliary cholangitis.

IF 1.7 Q2 MEDICINE, GENERAL & INTERNAL
Annals of Medicine and Surgery Pub Date : 2025-01-09 eCollection Date: 2025-01-01 DOI:10.1097/MS9.0000000000002868
Jawad Salamat Ali, Tooba Salamat Ali, Md Al Hasibuzzaman
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引用次数: 0

Abstract

Elafibranor (Iqirvo) has recently received FDA approval for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). This novel drug, a dual peroxisome proliferator-activated receptor-α/δ agonist, addresses the unmet need in PBC patients unresponsive to UDCA alone. Clinical trials, particularly the ELATIVE study, have shown significant biochemical improvements, including reduced alkaline phosphatase (ALP) levels and optimized lipid profiles. While common side effects include gastrointestinal discomfort, more severe but rare adverse effects, such as muscle injury and new-onset cholelithiasis, were observed. Elafibranor represents a promising advance in PBC management, offering enhanced efficacy with a tolerable safety profile. However, further research is needed to assess its long-term effectiveness and safety.

最新FDA批准的药物Elafibranor (Iqirvo):治疗原发性胆管炎的新前景。
Elafibranor (Iqirvo)最近获得FDA批准,用于联合熊脱氧胆酸(UDCA)治疗原发性胆管炎(PBC)。这种新型药物,双过氧化物酶体增殖物激活受体-α/δ激动剂,解决了对UDCA无反应的PBC患者的未满足需求。临床试验,特别是ELATIVE研究,显示了显著的生化改善,包括碱性磷酸酶(ALP)水平降低和脂质谱优化。虽然常见的副作用包括胃肠道不适,但更严重但罕见的副作用,如肌肉损伤和新发胆石症,也被观察到。Elafibranor代表了PBC管理的一个有希望的进步,提供了增强的疗效和可容忍的安全性。然而,需要进一步的研究来评估其长期有效性和安全性。
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
Annals of Medicine and Surgery
Annals of Medicine and Surgery MEDICINE, GENERAL & INTERNAL-
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5.90%
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