Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Winrevair (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity.

美国和加拿大以外的默克公司（Merck Inc.）宣布，欧盟委员会（EC）已批准Winrevair（sotatercept）联合其他肺动脉高压（PAH）疗法治疗世界卫生组织（WHO）功能II至III级成年患者的PAH，以提高运动能力。

Winrevair is the first and only activin signaling inhibitor therapy for PAH approved in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. Winrevair works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH.

Winrevair是欧盟所有27个成员国以及冰岛、列支敦士登和挪威批准的第一种也是唯一一种针对PAH的激活素信号抑制剂疗法。。

The EC approval of Winrevair is based on safety and efficacy results from the Phase III STELLAR trial..

欧共体对Winrevair的批准是基于III期STELLAR试验的安全性和有效性结果。。

“The European Commission’s approval of Winrevair is an important step for patients,” said Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories. “Winrevair is the first therapy targeting the activin signaling pathway. We are proud to bring this innovative treatment to more patients and remain committed to further investigating the potential of Winrevair in areas where there are unmet needs in the management of PAH.”.

默克研究实验室全球临床开发高级副总裁兼全科医学负责人Joerg Koglin博士说：“欧盟委员会批准Winrevair对患者来说是重要的一步。”。“Winrevair是第一种针对激活素信号通路的治疗方法。我们很自豪能将这种创新的治疗方法带给更多的患者，并继续致力于进一步研究Winrevair在PAH管理需求未得到满足的领域的潜力。”。

“Pulmonary arterial hypertension is a devastating disease for patients, who suffer from debilitating symptoms that can severely limit their daily activities,” said Dr. Marc Humbert, Professor of Medicine and Director of the Pulmonary Hypertension Reference Center at Université Paris-Saclay. “New treatment opinions continue to be needed for patients.

巴黎萨克莱大学医学教授兼肺动脉高压参考中心主任马克·亨伯特博士说：“肺动脉高压对患者来说是一种毁灭性的疾病，患者的虚弱症状会严重限制他们的日常活动。”。“患者仍然需要新的治疗意见。

Based on the Phase III STELLAR study, adding Winrevair to background PAH therapy improved exercise capacity, reduced the risk of death or clinical worsening events and improved functional class compared to background PAH therapy alone. These findings are significant and reinforce that Winrevair, in combination with other PAH therapies, should be considered as a new standard of care for the treatment of functional class II and III adult patients.”.

根据III期STELLAR研究，与单独的背景PAH治疗相比，在背景PAH治疗中添加Winrevair可提高运动能力，降低死亡或临床恶化事件的风险，并改善功能分级。这些发现意义重大，并强调Winrevair与其他PAH疗法相结合，应被视为治疗功能性II类和III类成年患者的新标准。”。

The EC approval is based on the Phase III STELLAR trial, which compared Winrevair (n=163) to placebo (n=160), both in combination with background standard of care therapies in adult patients with PAH (WHO Group 1, FC II or III). The primary efficacy endpoint was change from baseline at Week 24 in six-minute walk distance.

EC的批准是基于III期STELLAR试验，该试验将Winrevair（n=163）与安慰剂（n=160）进行了比较，两者均与成人PAH患者（WHO第1组，FC II或III）的背景护理标准疗法相结合。主要疗效终点是在6分钟步行距离内从第24周的基线变化。

Treatment with Winrevair resulted in a statistically significant and clinically meaningful improvement in six-minute walk distance of 40.8 meters over placebo (95% CI: 27.5, 54.1; p<0.001). winrevair also significantly improved multiple important secondary outcome measures, including reducing the risk of death or clinical worsening.

与安慰剂组相比，Winrevair治疗组的6分钟步行距离（40.8米）有统计学意义和临床意义的改善（95%可信区间：27.5,54.1；p<0.001）。winrevair还显着改善了多项重要的次要结局指标，包括降低死亡或临床恶化的风险。

in a post hoc analysis provided to ema, time to death or clinical worsening was defined as the time from randomization to the first occurrence of deterioration of pah, pah-specific hospitalization, worsening-related listing for lung and or heart transplant, need for atrial septostomy, or death from any cause.

在提供给ema的事后分析中，死亡时间或临床恶化被定义为从随机分组到首次发生pah恶化的时间，pah特异性住院，肺和/或心脏移植相关清单恶化，需要房间隔造口术，或任何原因导致的死亡。

there was an 82% reduction in the risk of death or clinical worsening with winrevair on top of background therapy versus background therapy alone (number of events: 7 vs 29, hr='0.182;' 95% ci: 0.075, 0.441; p><0.001)..

与单独背景治疗相比，winrevair在背景治疗的基础上降低了82%的死亡或临床恶化风险（事件数：7比29，hr='0.182；'95%ci:0.075，0.441；p><0.001）。。

Winrevair is administered once every 3 weeks as a single injection under the skin and may be administered by patients or caregivers with guidance, training and follow-up from a healthcare provider. Healthcare providers and patients/caregivers should refer to the Instructions for Use for information on the proper preparation and administration of Winrevair..

Winrevair每3周一次，作为皮肤下的单次注射，可由患者或护理人员在医疗保健提供者的指导，培训和随访下进行。医疗保健提供者和患者/护理人员应参考使用说明，了解Winrevair的正确制备和管理信息。。

Condition: Pulmonary Arterial Hypertension

病情：肺动脉高压

Type: drug

类型：药物