Merck Competes With Sanofi/AstraZeneca As Its RSV Treatment Drug Meets Primary Goal In Late-Stage Study In Infants
Merck Competes With Sanofi/AstraZeneca As Its RSV Treatment Drug Meets Primary Goal In Late-Stage Study In Infants
On Tuesday, Merck & Co Inc (NYSE:MRK) shared topline results from its Phase 2b/3 clinical trial (MK-1654-004) of clesrovimab (MK-1654).
默沙东于星期二分享了其第2b/3期临床试验（Mk-1654-004）clesrovimab（Mk-1654）的最新结果。
Clesrovimab is the company's investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease.
Clesrovimab是该公司调查性的预防性单克隆抗体，旨在保护婴儿免受呼吸道合胞病毒（RSV）疾病的侵害。
Clesrovimab met its primary safety and efficacy endpoints in the trial, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150.
在试验中，clesrovimab在主要安全性和疗效终点方面均达到了预期目标，包括减少RSV引起的医疗就诊的下呼吸道感染（MALRI）至第150天。
Participants were randomized to receive either a single dose of clesrovimab or a placebo.
受试者被随机分配接受一次性的clesrovimab或安慰剂。
Detailed study findings will be presented at an upcoming scientific congress, and Merck plans to file these data with global regulatory authorities.
详细的研究发现将在即将召开的科学大会上展示，并计划向全球监管当局提交这些数据。
Sanofi SA (NASDAQ:) /AstraZeneca Plc's (NASDAQ:AZN) Beyfortus (nirsevimab) received FDA approval in June 2023 for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants.
赛诺菲安万特和阿斯利康的Beyfortus（nirsevimab）于2023年6月获得FDA批准，用于预防新生儿和婴儿的呼吸道合胞病毒（RSV）下呼吸道疾病（LRTD）。
Sanofi and AstraZeneca revealed data from a real-world trial in May 2023.
赛诺菲和阿斯利康于2023年5月公布了一项来自实际情况的试验结果。
The phase 3 HARMONIE study recruited over 8,000 infants 12 months and younger.
第3期HARMONIE研究招募了超过8,000名12个月及以下的婴儿。
Infants who received a single dose of the antibody were 83% less likely to be hospitalized than those who were not inoculated.
接种一次性抗体的婴儿住院的可能性降低了83％，而未接种疫苗的婴儿则较高。
Most recently, Japan approved Beyfortus (nirsevimab) for the prophylaxis of lower respiratory tract disease caused by respiratory syncytial virus in all neonates, infants, and children.
最近，日本为新生儿、婴儿和儿童的呼吸道合胞病毒引起的下呼吸道疾病批准了Beyfortus（nirsevimab）的预防接种。
Pfizer Inc's (NYSE:PFE) maternal RSV vaccine, Abrysvo, is available as a preventive measure for young infants.
辉瑞公司的RSV疫苗Abrysvo可作为预防幼儿的措施进行接种。
It is advised to be given to women 32 to 36 weeks into a pregnancy to prevent lower respiratory tract infection and severe disease in infants until they are six months old.
建议在孕期32至36周给予孕妇，以预防婴儿的下呼吸道感染和严重疾病，直到他们6个月大。
Price Action: MRK stock is down 0.77% at $124.72 at the last check on Tuesday.
MRk股价在星期二的最后检查中下跌0.77％至124.72美元。
- Pfizer's RSV Vaccine Abrysvo Clears Concerns Over Preterm Birth Risk, Safety For Pregnant Women, New Study Shows.
- 辉瑞RSV疫苗Abrysvo的最新研究显示，已消除早产风险、孕妇安全问题。
Photo Courtesy of Merck
图片由默沙东提供