重新定义肺动脉高压治疗：索他西普获美国食品药品监督管理局优先审评
Redefining Pulmonary Arterial Hypertension Treatment: Sotatercept's FDA Priority Review.
作者信息
Kumar Harendra, Dhali Arkadeep, Biswas Jyotirmoy, Dhali Gopal Krishna
机构信息
General Medicine, Dow University of Health Sciences, Karachi, PAK.
Internal Medicine, Sheffield Teaching Hospitals National Health Service (NHS) Foundation Trust, Sheffield, GBR.
出版信息
Cureus. 2024 Aug 6;16(8):e66253. doi: 10.7759/cureus.66253. eCollection 2024 Aug.
Abstract
A biologics license application (BLA) for sotatercept, a therapeutic agent targeting activin receptor signaling implicated in pulmonary arterial hypertension (PAH), has been granted priority review status by the FDA. This advancement underscores the critical need for novel pharmacological interventions for this rare and severe condition, potentially transforming the therapeutic landscape of PAH.
摘要
一种针对与肺动脉高压（PAH）相关的激活素受体信号传导的治疗药物索他西普的生物制品许可申请（BLA）已获得美国食品药品监督管理局（FDA）的优先审评资格。这一进展突显了针对这种罕见且严重疾病的新型药物干预措施的迫切需求，有望改变PAH的治疗格局。
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本文引用的文献
1
Population Health Model Predicting the Long-Term Impact of Sotatercept on Morbidity and Mortality in Patients with Pulmonary Arterial Hypertension (PAH).人口健康模型预测 Sotatercept 对肺动脉高压（PAH）患者发病率和死亡率的长期影响。
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Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial.索特立塞特对血液动力学和右心功能的影响：STELLAR 试验分析。
Eur Respir J. 2023 Sep 21;62(3). doi: 10.1183/13993003.01107-2023. Print 2023 Sep.
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Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension.索他洛尔治疗肺动脉高压的3期试验
N Engl J Med. 2023 Apr 20;388(16):1478-1490. doi: 10.1056/NEJMoa2213558. Epub 2023 Mar 6.
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Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies.索他西普（ACE-011）用于治疗接受铂类化疗方案治疗的转移性乳腺癌或晚期或转移性实体瘤患者化疗引起的贫血：两项2期研究结果
Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 2015 Sep 14.
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