Flurpiridaz F 18

全球药物批准/研发动态 01 全球新药批准情况 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）全球（不含中国）共有5个新药获批上市。其中，NDA批准2个，BLA批准1个，新组合疗法批准1个，新适应症批准1个。与上个统计周期相比，本次减少8个批准新药。 9月27日，GE HealthCare宣布FDA批准Flyrcado（Flurpiridaz F 18）注射液用于已知或疑似冠状动脉疾病（CAD）的成年患者在休息或应激（药物或运动）下的正电子发射断层扫描（PET）心肌灌注成像（MPI），以评估心肌缺血和梗死。Flyrcado具有更高的诊断效力，半衰期为109分钟，无需现场生产和发生器维护，并能够分销到广泛的医院和成像中心网络。 9月30日，Fresenius Kabi宣布，FDA已批准了引用Stelara®（Ustekinumab）的乌司奴单抗生物仿制药的Otulfi™（Ustekinumab-aauz），用于治疗克罗恩病、溃疡性结肠炎、中度至重度斑块状银屑病和活动性银屑病关节炎。Otulfi™在中度至重度寻常型银屑病（斑块状银屑病）患者中显示出与参比药物Stelara®相当的疗效、安全性、药代动力学和免疫原性。Otulfi™被批准用于皮下和静脉制剂。Otulfi™禁用于对Ustekinumab或任何赋形剂有显著超敏反应的患者。 全球（不含中国）新药批准情况（部分） 02 全球新药申报进展 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）全球（不含中国）共有8个新药申报上市。其中，NDA申报4个，BLA申报4个。与上次统计周期相比，本次增加2个NDA/BLA申报。 10月3日，AstraZeneca针对Calquence（Acalabrutinib）的补充新药上市申请已在美国被接受并授予优先审评，用于治疗既往未经治疗的套细胞淋巴瘤成人患者。将Calquence联合疗法患者的中位无进展生存期增加了近1.5年，其中mPFS为66.4个月，而SoC组为49.6个月。 NDA/BLA申报（部分） 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）全球（不含中国）共有5个药物获监管机构特殊资格认定。其中，化学药4个，生物药1个。本次获监管机构特殊资格认定的药物数量与上次统计周期相同。 10月1日，Papillon Therapeutics宣布FDA已授予PPL-002孤儿药资格认定，这是一种实验性基因修饰的CD34+造血干细胞和祖细胞（HSPC）疗法，用于治疗Danon病。这种疗法旨在表达功能性Lamp-2蛋白，该蛋白在Danon病患者中严重缺乏。在临床前研究中，PPL-002已被证明可以改善受影响组织的疾病表型。PPL-002的治疗方法涉及同时靶向患者的多个器官系统，具有改变和逆转疾病进展的潜力。 10月2日，Volastra Therapeutics宣布FDA已授予KIF18A抑制剂VLS-1488快速通道资格，用于治疗铂类耐药高级别浆液性卵巢癌（HGSOC）。VLS-1488的I/II期试验正在评估晚期肿瘤（包括HGSOC）患者的安全性、耐受性和初步疗效。Volastra的两种KIF18A抑制剂VLS-1488和Sovilnesib中的每一种都具有独特的特征，并且都在招募患者进行早期研究。 特殊资格认定情况（部分） 03 全球新药研发进展 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）全球（不含中国）新药临床研发状态更新共计55条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及免疫系统疾病等共计14个领域。 其中，肿瘤领域临床进展更新居各领域之首，为17条：涉及化学药7条，生物药10条。 9月27日，科伦博泰在2024年CSCO学术年会上发表了TROP2 ADC芦康沙妥珠单抗（sac-TMT)治疗转移性三阴性乳腺癌（TNBC）的多项临床研究成果及进展。结果显示，芦康沙妥珠单抗组中位PFS为6.7个月，疾病进展或死亡的风险降低68%；OS期中分析显示化疗组的中位OS为9.4个月；HR为0.53，sac-TMT相比化疗发生死亡的风险降低47%。 10月3日，映恩生物在Clinicaltrial.gov网站上注册了DB-2304的I期临床试验。DB-2304为一款BDCA2 ADC新药，采用激素类似物作为paylaod，DAR值为4。BDCA2主要在pDC上表达，DB-2304结合后内吞并释放激素类似物到细胞中，促进抑制促炎细胞因子分泌的糖皮质激素反应基因的转录，抗体的结合本身也会抑制pDC活化和干扰素的产生，两种机制发挥协同效应。临床前研究证明这种协同效应的存在，DB-2304相比于临床上的BDCA2抗体可以更好的抑制炎性细胞因子的释放。 全球新药研发进展详情（部分） 04 全球医药交易事件 本次统计周期（2024.09.28-10.04）全球（含中国）医药交易时间共计30起，涉及药物权益转让、公司并购等多起交易事件。 全球医药交易时间汇总表（部分） 国内药物批准/研发动态 01 国内新药批准情况 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有3个新药获NMPA批准上市。其中，BLA批准2个，新适应症批准1个。本次NMPA批准新药数量与上个统计周期相同。 9月30日，NMPA官网显示，康方生物的PD-1/CTLA-4双特异性抗体开坦尼®（卡度尼利单抗注射液）新适应症上市申请的技术审评建议结论状态更新为：制证完毕-待发批件，该新适应症为：卡度尼利联合含氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除或转移性胃或胃食管结合部（G/GEJ）腺癌患者的一线治疗。COMPASSION-15研究中，PD-L1 CPS＜5和PD-L1 CPS＜1人群占意向治疗人群的比例分别达49.8%和23%。 9月30日，NMPA宣布齐鲁制药1类新药艾帕洛利单抗托沃瑞利单抗注射液上市申请已获得批准，适应症为用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。II期临床研究结果显示，ORR为33.8%，达预设主要终点，DCR为64.9%，PFS达到5.4个月，70.3%受试者发生了治疗相关不良事件。试验数据表明艾帕洛利托沃瑞利单抗作为复发/转移宫颈癌的后线治疗有效且安全。 国内新药批准情况（部分） 02 国内新药临床默示许可进展 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有17个新药获临床默示许可，涉及20个受理号。其中，化学药6个，治疗用生物制品11个。与上次统计周期相比，本次减少32个临床默示许可获批受理号。 本周国内新药临床默示许可进展（部分） 03 国内新药申报进展 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有7个新药申报上市，涉及8个受理号。其中，化药4个，治疗用生物制品1个，预防用生物制品2个。与上个统计周期相比，本次减少3个新药申报上市受理号。 国内新药申报上市情况（部分） 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有15个新药申报临床，涉及25个受理号。其中，化学药9个，治疗用生物制品5个，预防用生物制品1个。与上次统计周期相比，本次减少79个临床申报受理号。 国内新药临床申报情况（部分） 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内共有2个药物获NMPA特殊资格认定。其中，化学药2个。与上次统计周期相比，本次减少4个获监管机构特殊资格认定的药物。 10月2日，CDE官网公示，恒瑞医药2.2类改良型新药HR19042胶囊拟纳入突破性治疗品种，针对适应症为活动性自身免疫性肝炎。HR19042是一款口服胶囊剂，能增强内皮细胞、平滑肌细胞和溶酶体膜的稳定性，抑制免疫反应和降低抗体合成，从而使组胺等过敏活性介质的释放减少和活性降低。恒瑞医药正在针对HR19042胶囊开展两项临床研究，分别为一项治疗自身免疫性肝炎的有效性和安全性研究的II期临床研究，以及一项治疗原发性IgA肾病的II/III期临床研究。 10月3日，CDE官网公示，迪哲医药申报的DZD9008片拟纳入突破性治疗品种，针对适应症为未接受过系统性治疗、携带EGFR 20号外显子插入突变的局部进展或转移性非小细胞肺癌（NSCLC）。舒沃替尼单药一线治疗EGFR exon20ins突变型晚期NSCLC的经确认cORR达78.6%，RP2D 300mg组mPFS为12.4个月，再次展现“高效低毒”的治疗潜力。目前III期临床研究WU-KONG28已在中国、欧美等多个国家开展。 国内监管机构特殊资格认定药物 04 国内新药研发进展 根据药渡数据统计分析，本次统计周期（2024.09.28-10.04）国内新药临床研发状态更新共计5条，涉及免疫系统、血液和淋巴系统疾病和皮肤病共计3个领域。其中，化学药1条，生物药3条，细胞疗法1条。与上次统计周期相比，本次减少2条国内新药临床研发状态更新。 9月29日，驯鹿生物在2024 IMS年会上展示了其全人源靶向BCMA的CAR-T疗法——伊基奥仑赛注射液在治疗复发难治性多发性骨髓瘤（R/R MM)的FUMANBA-1研究中不同淋巴细胞清除方案下的比较研究。研究结果表明足量的淋巴细胞清除预处理能够显著提升患者的缓解深度，延长缓解时间和无进展生存期。标准剂量组的ORR和严格意义上的sCR分别为100%和82.8%，两组在CRS和ICANS的严重程度和发生率上没有显著差异。 10月2日，康方生物的靶向于IL-12/IL-23的全人源单克隆抗体依若奇治疗中、重度斑块型银屑病受试者长期安全性和有效性III期临床研究结果于近日在EADV congress 2024向全球学界领域专家展示。依若奇短长期疗效均优异、长期疗效稳定，在减少银屑病面积和严重程度方面表现出色。患者在AK101-302研究中接受了对照药16周治疗后，第16周切换到依若奇治疗，PASI75应答率在第32周提升至81.4%，sPGA0/1达成率提升至71.1%，并在第52周稳定维持。 国内新药研发进展（部分） 05 国内新药研发领域政策法规动态 关于公开征求《生物类似药说明书撰写技术指导原则（征求意见稿）》意见的通知 自2015年发布《生物类似药研发与评价技术指导原则（试行）》以来，国内已有多家制药企业开展生物类似药研发，部分已获准上市。为规范生物类似药说明书科学撰写，药审中心在已有经验的基础上，结合该类药物的研发特点，组织起草了《生物类似药说明书撰写技术指导原则》，现形成征求意见稿。 我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议，并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻 今日！康方生物双喜临门，两款抗体药物获批 9月30日，从中国国家药监局（NMPA）及康方生物官网公示可知，康方生物PCSK9单抗伊努西单抗注射液（AK102）上市申请已正式获批；PD-1/CTLA-4双特异性抗体卡度尼利单抗注射液新适应症获批。 伊努西单抗注射液 伊努西单抗适应症为：在控制饮食的基础上，与他汀类药物、或者与他汀类药物及其他降脂疗法联合用药，用于在接受中等剂量或中等以上剂量他汀类药物治疗后，仍无法达到低密度脂蛋白胆固醇（LDL-C）目标的原发性高胆固醇血症（包括杂合子型家族性和非家族性高胆固醇血症）和混合型血脂异常的成人患者。更多资讯，请阅读原文 齐鲁制药PD-1/CTLA-4双功能组合抗体获批上市 9月30日，从中国国家药品监督管理局（NMPA）官网公示，齐鲁制药申报的艾帕洛利托沃瑞利单抗注射液（商品名：齐倍安）获附条件批准上市，适应症为既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。 艾帕洛利托沃瑞利单抗注射液（艾托组合抗体，研发代号QL1706）是全球首个获批上市的PD-1/CTLA-4双功能组合抗体，由IgG4型PD-1抗体和IgG1型CTLA-4抗体按照特定的比例组成。CTLA-4和PD-1通路均能负向调节T细胞免疫功能，艾托组合抗体能同时靶向和阻断这两条免疫检查点信号通路，激活抗肿瘤免疫反应。更多资讯，请阅读原文 咨询、合作请联系作者 小D有话说 为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“1016创新药周报”，即可下载。

GE HealthCare’s FDA-approved flurpiridaz F 18 PET radiotracer, Flyrcado, delivers higher diagnostic efficacy in patients with known or suspected coronary artery disease (CAD), compared to SPECT MPI, the predominant procedure used in nuclear cardiology today With a half-life over ten times longer than currently approved cardiac PET radiotracers, Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD Available as a unit dose - or ready-to-use, Flyrcado has the potential to expand clinician and patient access to PET myocardial perfusion imaging (MPI) ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD). Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women 1 . With a half-life of 109-minutes—significantly longer than existing PET MPI tracers—Flyrcado removes the need for on-site tracer production and generator maintenance and enables distribution to a wide network of hospitals and imaging centers. This longer half-life also means Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, enabling the most robust protocol for evaluating ischemia in patients. Furthermore, clinicians would have the ability to rescan a patient during the same imaging session in the event of technical difficulties, rather than rescheduling an additional scan. Dr. Jamshid Maddahi, MD, FACC, MASNC, principal investigator of the Flyrcado clinical trials, clinical professor of medicine (cardiology) and molecular and medical pharmacology (nuclear medicine) at UCLA School of Medicine and director of the Biomedical Imaging Institute, said, “Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades. Although PET MPI as a modality enables high diagnostic accuracy as compared to SPECT MPI 2 , only a minority of annual PET scans in the US are PET MPI because of limited access to the currently available PET tracers—which may be addressed with the introduction of Flyrcado. 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.” CAD is the most common form of heart disease and remains the leading cause of death for men and women in the U.S. 3 , with 695,000 deaths recorded in 2021 4 . During the multicenter international AURORA Phase III trial, flurpiridaz F 18 was compared with both invasive coronary angiography as a standard of truth to determine diagnostic efficacy in detecting CAD, as well as with SPECT MPI. Around six million MPI procedures are undertaken each year in the U.S. 5 to show blood flow through the heart muscle, and evaluate the presence, extent and degree of myocardial ischemia or infarction. Dr. Mouaz Al-Mallah, MD, MSc, MASNC, immediate Past President of the American Society of Nuclear Cardiology (ASNC) and Director of Cardiac PET at Houston Methodist Hospital, said “Given the desirable properties of flurpiridaz F 18, both in terms of myocardial uptake and fluorine-18 imaging characteristics, Flyrcado represents a favorable combination of imaging agent pharmacology and convenience to imaging institutions and patients. There are new frontiers for cardiac PET that this tracer can achieve; it can be ordered as a unit dose, and it offers the flexibility to perform exercise stress testing. We expect new imaging centers to be able to offer cardiac PET to their patients, making it more convenient to access PET MPI and providing a meaningful impact for clinicians and their patients.” Kevin O’Neill, CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said, “As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients. This is another example of GE HealthCare’s commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs.” Flyrcado is one of three F 18 imaging agents in GE HealthCare’s portfolio of FDA-approved molecular imaging PET products, joining radiopharmaceutical PET imaging agents Cerianna™ (fluoroestradiol F 18) injection, used to detect estrogen receptor positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer, and Vizamyl™ (flutemetamol F 18) injection which is a PET tracer for imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients who are being evaluated for Alzheimer’s disease or other causes of cognitive decline. GE HealthCare acquired exclusive global commercialization rights for flurpiridaz F 18 from Lantheus in 2017 and has led the funding and development of the product through to approval. Lantheus collaborated on the development and will also collaborate on commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales milestones. Flyrcado will be available in initial U.S. markets in early 2025 with expanding availability thereafter. As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and proprietary radiopharmaceuticals used across cardiology, neurology and oncology. The PDx segment is a global leader in imaging agents used to support over 120 million patient procedures per year globally, equivalent to four patient procedures every second. About GE HealthCare Technologies Inc. GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits. Follow us on LinkedIn , X , Facebook , Instagram , and Insights for the latest news, or visit our website for more information. INDICATIONS AND USAGE OF FLYRCADO™: FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information IMPORTANT SAFETY INFORMATION Indications and Usage FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. Contraindications None Warnings and Precautions Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information. Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void. Adverse Reactions Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. Use in Specific Populations Pregnancy There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. Lactation Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Pediatric Use Safety and effectiveness of FLYRCADO in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or For full prescribing information, click here . For important safety information, please click here . INDICATIONS AND USAGE OF CERIANNA™: INDICATIONS AND USAGE CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). CONTRAINDICATIONS None. ADVERSE REACTIONS In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare Company at 800.654.0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 1-800-FDA-1088 or . For full Prescribing Information click here . INDICATIONS AND USAGE OF VIZAMYL™: PRODUCT INDICATIONS AND USE VIZAMYL™ (Flutemetamol F 18) injection is indicated for positron-emission tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline. A negative scan indicates sparse to no neuritic plaques, inconsistent with a diagnosis of AD at the time of image acquisition. A negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also be present in patients with other neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. Limitations: A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies. Important Safety Information About VIZAMYL ™ (Flutemetamol F 18) injection CONTRAINDICATIONS • Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80 ADVERSE REACTIONS • The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%) For full prescribing information, including additional important safety information, please click here . 1 Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, BermanDS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients with Suspected Coronary Artery Disease. J AmColl Cardiol. 2023; 82:1598–1610 2 Schindler, T. H., Bateman, T. M., Berman, D. S., Chareonthaitawee, P., De Blanche, L. E., Dilsizian, V., Dorbala, S., Gropler, R. J., Shaw, L., Soman, P., Winchester, D. E., Verberne, H., Ahuja, S., Beanlands, R. S., Di Carli, M. F., Murthy, V. L., Ruddy, T. D., & Schwartz, R. G. (2020). Appropriate use criteria for PET myocardial perfusion imaging. Journal of Nuclear Medicine, 61 (8), 1221-1265. 3 Friede A, O’Carroll PW, Thralls RB, Reid JA. CDC WONDER on the web. Proc AMIA Annu Fall Symp. 1996:408–412. 4 Tsao CW, Aday AW, Almarzooq ZI, et al. Heart disease and stroke statistics—2023 update: A report from the American Heart Association. Circulation. 2023;147: e93–e621. . 5 Miller, R. J. H., Bednarski, B. P., Pieszko, K., Kwiecinski, J., Williams, M. C., Shanbhag, A., Liang, J. X., Huang, C., Sharir, T., Hauser, M. T., Dorbala, S., Di Carli, M. F., Fish, M. B., Ruddy, T. D., Bateman, T. M., Einstein, A. J., Kaufmann, P. A., Miller, E. J., Sinusas, A. J., Acampa, W., Han, D., Dey, D., Berman, D. S., & Slomka, P. J. (2024). Clinical phenotypes among patients with normal cardiac perfusion using unsupervised learning: A retrospective observational study. EBioMedicine , 99, 104930. Contacts GE HealthCare Media Contact: Emmy Elguizaoui +1 (978) 243-7503 Emmy.Elguizaoui@gehealthcare.com