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).
默沙東於星期二分享了其第2b/3期臨床試驗（Mk-1654-004）clesrovimab（Mk-1654）的最新結果。
Clesrovimab is the company's investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease.
Clesrovimab是該公司調查性的預防性單克隆抗體，旨在保護嬰兒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.
在試驗中，clesrovimab在主要安全性和療效終點方面均達到了預期目標，包括減少RSV引起的醫療就診的下呼吸道感染（MALRI）至第150天。
Participants were randomized to receive either a single dose of clesrovimab or a placebo.
受試者被隨機分配接受一次性的clesrovimab或安慰劑。
Detailed study findings will be presented at an upcoming scientific congress, and Merck plans to file these data with global regulatory authorities.
詳細的研究發現將在即將召開的科學大會上展示，並計劃向全球監管當局提交這些數據。
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.
賽諾菲安萬特和阿斯利康的Beyfortus（nirsevimab）於2023年6月獲得FDA批准，用於預防新生兒和嬰兒的呼吸道合胞病毒（RSV）下呼吸道疾病（LRTD）。
Sanofi and AstraZeneca revealed data from a real-world trial in May 2023.
賽諾菲和阿斯利康於2023年5月公佈了一項來自實際情況的試驗結果。
The phase 3 HARMONIE study recruited over 8,000 infants 12 months and younger.
第3期HARMONIE研究招募了超過8,000名12個月及以下的嬰兒。
Infants who received a single dose of the antibody were 83% less likely to be hospitalized than those who were not inoculated.
接種一次性抗體的嬰兒住院的可能性降低了83％，而未接種疫苗的嬰兒則較高。
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，日本爲新生兒、嬰兒和兒童的呼吸道合胞病毒引起的下呼吸道疾病批准了Beyfortus（nirsevimab）的預防接種。
Pfizer Inc's (NYSE:PFE) maternal RSV vaccine, Abrysvo, is available as a preventive measure for young infants.
輝瑞公司的RSV疫苗Abrysvo可作爲預防幼兒的措施進行接種。
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.
建議在孕期32至36周給予孕婦，以預防嬰兒的下呼吸道感染和嚴重疾病，直到他們6個月大。
Price Action: MRK stock is down 0.77% at $124.72 at the last check on Tuesday.
MRk股價在星期二的最後檢查中下跌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.
- 輝瑞RSV疫苗Abrysvo的最新研究顯示，已消除早產風險、孕婦安全問題。
Photo Courtesy of Merck
圖片由默沙東提供