Sept. 30, 2024 – A newly FDA-approved drug will improve the diagnosis of coronary artery disease, the most common type of heart disease, which impacts more than 18 million adults in the U.S. and is the leading cause of death nationwide. Given as a shot before heart imaging tests, the drug – called flurpiridaz and marketed under the brand name Flyrcado – is a radiotracer, a substance that helps doctors see inside the body during a scan.

2024年9月30日，美国食品和药物管理局（FDA）批准的一种新药物将改善冠状动脉疾病的诊断，冠状动脉疾病是最常见的心脏病，影响美国1800多万成年人，是全国主要的死亡原因。这种名为氟哌咪唑（flurpiridaz）的药物是一种放射性示踪剂，可以帮助医生在扫描过程中看到身体内部，它是在心脏成像测试之前注射的。

The approval was made using the agency’s priority review process, reserved for drugs that address serious conditions and work significantly better than existing options. The current standard for examining blood flow through the heart and evaluating suspected coronary artery disease (CAD) is myocardial perfusion imaging with single photon emission computed tomography.

该批准是使用该机构的优先审查程序进行的，该程序保留用于解决严重疾病且效果明显优于现有选择的药物。目前检查心脏血流和评估可疑冠状动脉疾病（CAD）的标准是单光子发射计算机断层扫描的心肌灌注成像。

It’s also known as a nuclear stress test. With Flyrcado, the test can now be done using a PET scan – known to be better at detecting CAD, but not widely used because of challenges posed by other radiotracers.  “Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades,” Jamshid Maddahi, MD, the lead researcher for the Flyrcado clinical trials and a clinical professor at the UCLA School of Medicine, said in a news release from GE HealthCare, the drug’s maker.

它也被称为核压力测试。有了Flyrcado，现在可以使用PET扫描来完成测试-众所周知，PET扫描可以更好地检测CAD，但由于其他放射性示踪剂带来的挑战，该测试尚未得到广泛应用。Flyrcado临床试验首席研究员、加州大学洛杉矶分校医学院临床教授Jamshid Maddahi博士在药物制造商GE HealthCare发布的新闻稿中表示：“Flyrcado是过去几十年来核心脏病学领域最令人兴奋的发展。”。

“I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world.”While other radiotracers must be produced on-site where the tests happen, Flyrcado can be made off-site and arrive at test locations ready to use.

“作为一个游戏规则的改变者，我对这种新的放射性示踪剂及其潜在的影响感到兴奋，因为它可以诊断出世界上死亡率最高的疾病。”虽然其他放射性示踪剂必须在测试发生的现场生产，但Flyrcado可以在场外制作并到达测试地点准备使用。

It lasts at least 109 minutes, potentially allowing for more testing in one session as well as time for repeat testing, if needed.An estimated 6 million people get imaging for su.

它至少持续109分钟，如果需要的话，可能允许在一个会话中进行更多测试，以及重复测试的时间。估计有600万人接受su成像。