Vericiguat

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck & Co. (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of clinical data from its broad and advancing cardiovascular pipeline and portfolio at the upcoming American College of Cardiology’s 72nd Annual Scientific Session together with World Heart Federation’s World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA from March 4-6, 2023. Two Merck studies will be featured in a late-breaking clinical trial session: the first presentation of detailed findings from the pivotal Phase 3 STELLAR trial evaluating sotatercept, an investigational activin signaling inhibitor therapy, as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension (PAH), and results from a Phase 2b trial evaluating MK-0616, an investigational oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, for the treatment of hypercholesterolemia. “At this year’s ACC and WCC meeting, we’re thrilled to share major updates for two promising investigational medicines from our robust cardiovascular pipeline,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to sharing the Phase 3 data for sotatercept, a novel therapeutic approach that we believe has the potential to transform the treatment of patients with PAH. We’re also proud to continue to build on our company’s unique heritage in treatments for cardiovascular diseases by sharing clinical data from our oral PCSK9 inhibitor program. These exciting data, together with new data for our approved medicines, reflect the strength of our innovative cardiovascular pipeline and our commitment to help improve outcomes for people with cardiovascular disease.” Details on selected studies by Merck The STELLAR Phase III trial: a study of sotatercept in combination with background therapy for the treatment of pulmonary arterial hypertension Author: Hoeper Late-Breaking Clinical Trials V Abstract: #LBA 410-14 Session time: Monday, March 6, 11 a.m.-12:15 p.m. CST (Great Hall) Presentation time: 11:45-11:55 a.m. CST Late-Breaking Clinical Trials Deep Dive II Abstract: #LBA 413-15 Session time: Monday, March 6, 2:30-3:45 p.m. CST (La Nouvelle B) Presentation time: 3:30-3:35 p.m. CST In October 2022, Merck announced that STELLAR met its primary efficacy outcome measure, demonstrating a statistically significant and clinically meaningful improvement in six-minute walking distance from baseline at 24 weeks as an add-on to stable background therapy. Efficacy and safety of the oral PCSK9 inhibitor, MK-0616, a macrocyclic peptide, in the treatment of hypercholesterolemia: a Phase 2b randomized placebo-controlled clinical trial Author: Ballantyne Abstract: #LBA 410-16 Session time: Monday, March 6, 11 a.m.-12:15 p.m. CST (Great Hall) Presentation time: 12-12:10 p.m. CST Contemporary therapy of pulmonary arterial hypertension across the globe Author: White Abstract: #1535-031 Session time: Sunday, March 5, 11:45 a.m.-12:30 p.m. CST (Hall F) Who? Characterizing vericiguat use in a real-world HFREF patient population Author: Victores Abstract: #1006-13 Session time: Saturday, March 4, 11-11:10 a.m. CST (Hall F) NT-ProBNP during screening in the study of vericiguat in participants with heart failure with reduced ejection fraction (VICTORIA) trial: insights into outcomes and vericiguat Author: Westerhout Abstract: #1768-154 Session time: Monday, March 6, 11:45 a.m.-12:30 p.m. CST (Hall F) Merck Investor Event Merck will host an investor event on Monday, March 6 at 6 p.m. CST (7 p.m. EST) to discuss data presented at ACC.23/WCC and provide an update on the progress of the company’s cardiovascular pipeline, followed by a question-and-answer session. Investors, analysts, members of the media and the general public are invited to listen to a live webcast of the presentation at . About sotatercept Sotatercept is an investigational, potential first-in-class activin signaling inhibitor biologic being studied for the treatment of PAH (WHO Group 1). PAH is a rare disease caused by hyperproliferation of cells in the arterial walls in the lung, leading to narrowing and abnormal constriction. In pre-clinical models, sotatercept has been shown to modulate vascular cell proliferation, reversing vascular and right ventricle remodeling. Sotatercept has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA), as well as Priority Medicines designation by the European Medicines Agency for the treatment of PAH. Merck acquired exclusive rights to sotatercept in the pulmonary hypertension field through the acquisition of Acceleron Pharma Inc. Sotatercept is the subject of a licensing agreement with Bristol Myers Squibb. About MK-0616 MK-0616 is an investigational, potentially first oral PCSK9 inhibitor designed to lower low density lipoprotein (LDL) cholesterol. MK-0616 is a macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors. This results in greater numbers of LDL receptors available on the cell surface to remove LDL cholesterol from the blood. About VERQUVO® (vericiguat) tablets for once daily oral use (2.5 mg, 5 mg, and 10 mg) VERQUVO is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation. Selected Safety Information for VERQUVO WARNING: EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm. VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. VERQUVO is contraindicated in pregnancy. Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose. In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency greater than or equal to 5%, were hypotension (16% vs 15%) and anemia (10% vs 7%). There are no data on the presence of VERQUVO in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO. Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension. The vericiguat program is co-developed by Bayer and Merck. Merck has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat. Merck’s focus on cardiovascular disease Merck has a long history of making an impact in cardiovascular disease. More than 60 years ago, we introduced our first cardiovascular therapy – and our scientific efforts to understand cardiovascular-related disorders have continued. Cardiovascular disease continues to be one of the most serious health challenges of the 21st century. Approximately 18 million people across the globe die every year, and in the United States one person dies every 36 seconds from cardiovascular disease. Advancements in the treatment of cardiovascular disease can make a critical difference for patients around the world. At Merck, we strive for scientific excellence and innovation in all stages of research, from discovery through approval and life cycle management. We work with experts throughout the cardiovascular and pulmonary community to advance research that can help improve the lives of patients globally. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2021 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). Please see Prescribing Information, including Boxed Warning, for VERQUVO (vericiguat) at and Medication Guide at .

点击上方 一键预约      最新最热的医药健康新闻政策前言2022年，全球批准新药数量水平较为稳定，FDA共完成802项药品首次批准（不包含暂时批准），其中批准121款新药（NDA/BLA），包含23款新获批的新分子实体药物（NDA：Type 1 - New Molecular Entity），25款生物制品药物（BLA）。EMA共授权96款药品上市，包含47款新活性物质药。随着新冠疫情防控措施的实时调整，以及2021年批准创新药上市的优异表现，导致2022年国内创新药获批数量呈断崖式下跌。NMPA批准创新药22个品种上市（不含特别审批用于预防/治疗新冠的4个品种），包含6款中药，10款化药和6款生物制品。2022年NMPA批准了首个按古代经典名方目录管理的中药复方制剂（即中药3.1类新药）苓桂术甘颗粒上市，是推进古代经典名方向新药转化的一次生动实践。仿制药一致性评价工作继续稳步推行，2022年过评1528个品规，其中注射剂占比约51%。2022年医疗器械方面，FDA有22个通过上市前批准（PMA）途径首次上市的产品。境内公示了67个三类医疗器械进入创新审批绿色通道，批准了54个创新器械上市，境内医疗器械审批集中在体外诊断试剂，共12628项，占29.14%。01全球药品获批情况（一）美国FDA批准情况图1 2013—2022年FDA药物批准数量变化情况来源：美国食品药品监督管理局如图1，截至2023年1月5日FDA官网披露，2022年FDA共完成802项药品首次批准（不包含暂时批准），其中NDA/BLA批准121款（不包含暂时批准)。其中包括23款新获批的新分子实体药物（NDA：Type 1 - New Molecular Entity），见表1，25款生物制品药物（BLA）。表1 2022年FDA批准新分子实体药物来源：美国食品药品监督管理局（二）欧盟EMA批准情况截至2023年1月5日EMA官网披露，2013年至2022年的推荐上市药品及推荐上市新活性物质（NAS）数量情况见图2。图2 2013—2022年EMA推荐上市药品数量变化情况来源：火石创造产业数据中心截至2023年1月5日，2022年EMA共授权96款药品上市，其中授权47款新活性物质药，包含6款全球首创新药（first-in-class）。研发企业中，AstraZeneca AB和Novartis获授权上市药品最多，均有4款药品，Bristol-Myers Squibb、Eli Lilly、Genzyme、Pfizer、Roche五家药企各有2款药品上市，位列第二梯队。详细情况如列表2。表2  2022年EMA授权上市的新活性物质药物列表来源：火石创造产业数据中心（三）NMPA批准情况截至2023年1月5日NMPA披露，2022年共批准国产首次注册药品1001件。按剂型去重后，共428个药品品种（不同厂家生产同一药物按同一品种计算），共30个品规（22个品种）1类创新药获批上市，包含16个品规（10个品种）化药、8个品规（6个品种）生物制品和6个品规（6个品种）中药。按品规计，创新药获批同比2021年下降43.14%。2022年NMPA批准的1类创新药情况见表3。2022年上市创新药涉及企业21家，其中获批最多的企业为Bayer和武汉光谷人福公司，均获批了2个品种创新药。Bayer于2022年5月经优先审评审批上市的维立西呱片，是拜耳与默沙东联合开发的鸟苷酸环化酶（sGC）激动剂，已于2021年1月20日获得FDA批准，是一款全球首创新药（first-in-class），经过一年多的时间在国内也获批上市，其上市为症状性慢性心力衰竭成人患者提供了新的治疗选择；6月Bayer再上市一款治疗与2型糖尿病相关的慢性肾脏病用药：非奈利酮片，其是一种非甾体类、选择性盐皮质激素受体（MR）拮抗剂，在NMPA获批之前，已经在包括美国、欧洲在内的多个国家和地区上市。武汉光谷人福公司（人福医药）于2022年也获批上市了2个品种中药创新药，分别为广金钱草总黄酮提取物和广金钱草总黄酮胶囊，相对于目前临床多采用的外科碎石取石办法，广金钱草总黄酮可以减轻对身体的伤害。广金钱草总黄酮胶囊是全球首创的防治尿结石症中药新药，也是人福医药继1类化药苯磺酸瑞马唑仑、磷丙泊酚二钠之后，获批的第3个1类创新药。2022年NMPA共批准上市6个品种中药创新药，除上述人福医药的2个品种外，分别为1月获批的珅诺基药业淫羊藿素、淫羊藿素软胶囊，12月获批的安邦制药芪胶调经颗粒、华春生物参葛补肾胶囊。除这些1类创新药外，NMPA还于2022年12月28日公告批准首个按古代经典名方目录管理的中药复方制剂（即中药3.1类新药）苓桂术甘颗粒上市，该药品处方来源于汉·张仲景《金匮要略》，已列入《古代经典名方目录（第一批）》，上市许可持有人为江苏康缘药业。近年来，国家药监局积极贯彻落实《中华人民共和国中医药法》及其他文件有关规定和精神，积极配合国家中医药管理局发布古代经典名方目录及其关键信息考证意见。同时，国家药监局制定发布《古代经典名方中药复方制剂简化注册审批管理规定》，实施各项举措促进古代经典名方中药复方制剂研发。苓桂术甘颗粒的上市是深入发掘中医药宝库精华，推进古代经典名方向新药转化的一次生动实践。在2022年获批上市的1类创新药中，有5个品种属于全球首创新药（first-in-class），除上文中提到的拜耳公司维立西呱片、珅诺基药业淫羊藿素软胶囊、人福医药广金钱草总黄酮胶囊外，还有康方生物卡度尼利单抗注射液和华领医药多格列艾汀片。康方生物自主研发的卡度尼利单抗注射液是全球首款CRLA4/PD-1双抗，用于治疗复发或转移性宫颈癌，填补了国产双特异性抗体药物研发的市场空白，而最近康方生物另一款PD-1/VEGF双抗依沃西单抗的美国、加拿大、欧洲和日本权益授权给Summit Therapeutics公司，后者将支付5亿美元首付款，以及最高50亿美元的总交易金额，一跃成为2022年第二大国产新药海外授权交易（License out）；华领医药研发的多格列艾汀片是全球范围内首个获批上市的葡萄糖激酶激活剂药物，是过去十年来糖尿病领域首个全新机制的原创新药，也是首次在中国推出的2型糖尿病全球首创新药。表3  2022年NMPA批准的1类创新药获批列表来源：国家药品监督管理总局从地域分布上，2022年获批创新药企业最多的依次为上海市（4家企业，持4个品种药品）、山东省（3家企业，持3个品种药品）、北京市/江苏省（2家企业，持2个品种药品）几个区域，见图3。图3 2022年获批创新药区域分布来源：国家药品监督管理总局截至2023年1月5日，随着疫情防控政策调整，为预防/治疗COVID-19新冠病毒，2022年NMPA按照药品特别审批程序，进行应急审评审批，附条件批准了5个品规（4个品种）疫苗/药品的上市，见表4；同时，于12月30日，NMPA通过快速审评通道，批准布洛芬混悬液等12个新冠病毒感染对症治疗药物上市。 表4  2022年NMPA特别审批药物列表来源：国家药品监督管理总局（四）仿制药一致性评价情况截至2023年1月5日CDE官网披露，CDE共承办药品一致性评价受理号4426个，2022年共新增承办835个受理号。截至2023年1月5日，共5110个品规上市药品通过一致性评价（包含视同通过2199个品规），2022年共1528个品规的药品通过一致性评价（包含视同通过703个品规），按剂型去重后，共492个药品品种。目前一致性评价品种通过的注射剂共1901个品规（273个品种），2022年过评药品中共计777个品规（196个品种）的注射剂。2018年至2022年通过一致性评价数量见图4。图4 2018年至2022年仿制药一致性评价批准数量变化情况来源：国家药品监督管理总局02全球医疗器械获批情况（一）美国FDA批准情况截至2023年1月5日，2022年FDA共批准3229个510（k）途径的产品，其中一类器械262个，二类器械2895个，未分类72个。2022年共有22个通过上市前批准（PMA）途径首次上市。通过对510（k）上市前通知的器械根据美国医学专业用途进行分类，结果发现，2022年产品获批类型最多的为一般和整形手术器械、骨科器械、放射科器械、一般医院和个人使用类器械与心血管器械，见图5。图5 2022年通过FDA 510（k）途径获批上市产品类型分布情况来源：美国食品药品监督管理局表5  2022年PMA首次批准的器械来源：美国食品药品监督管理局（二）境内批准情况截至2023年1月5日，2022年国家局公示了67个三类医疗器械进入创新审批绿色通道，见表6。表6  2022年进入绿色通道的三类创新器械来源：国家医疗器械审评中心截至2023年1月5日，2022年国家局公示了54个三类创新器械获批上市，见表7。表7  2022年获批上市的三类创新器械来源：国家医疗器械审评中心截至2023年1月5日，2022年国家局共批准首次注册三类医疗器械产品2172个，其中国产1818个，进口354个。各省级药品监管部门2022年共批准国产第二类医疗器械注册13063个，一类备案医疗器械27117个。统计数据显示，体外诊断试剂数量最多，共12628项，占29.14%，基本上均为国产，为12415项。除体外诊断试剂，批准注册类别数量排前三位的分别为注输、护理和防护器械，临床检验器械和口腔科器械。表8 2022年国产、进口医疗器械批准注册类别数目分布情况来源：国家医疗器械审评中心从地域分布上，2022年国产二、三类注册产品批件最多的依次为广东省（2290件）、湖南省（2277件）、江苏省（2187件）三个区域，见图6。图6 国产获批器械区域分布来源：火石创造产业数据中心（来源:火石创造 作者:毛琦琼）药闻康策新媒体矩阵微信公众号点击下方  一键关注  【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看