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