AstraZeneca's COVID-19 Prevention Drug For Patients With Weak Immune Systems - European Medicines Agency Accepts Marketing Application Under Accelerated Assessment
AstraZeneca's COVID-19 Prevention Drug For Patients With Weak Immune Systems - European Medicines Agency Accepts Marketing Application Under Accelerated Assessment
The European Medicines Agency (EMA) has accepted AstraZeneca Plc's (NASDAQ:AZN) marketing authorization application for sipavibart for pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.
欧洲药品管理局(EMA)已接受阿斯利康公司(NASDAQ:AZN)的sipavibart获得新冠疫苗预防性前瞻性应用申请，用于免疫功能受损患者的预防措施。
AstraZeneca's application for sipavibart has been accepted under an accelerated assessment procedure.
阿斯利康的sipavibart申请已经采用加速评估程序被接受。
Also Read: AstraZeneca Targets Ambitious $80B In Total Revenue By 2030 Through Pipeline Expansion.
阿斯利康通过管道扩张计划，力争到2030年实现800亿美元的总营业收入。
Sipavibart is an investigational long-acting antibody designed to provide COVID-19 protection for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.
sipavibart是一种正在研究的长效抗体，旨在为免疫功能受损患者提供新冠病毒保护，这些患者通常对疫苗单独治疗反应不佳，且长期处于严重的新冠病毒风险中。
The EMA's Committee for Medicinal Products for Human Use granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation.
EMA的人类用药品委员会将sipavibart评估加速，因其被认为对公共卫生和治疗创新具有重大意义。
The accelerated assessment aims to reduce the timeframe for the CHMP to review the marketing application compared to the standard procedure.
加速评估目的在于缩短比标准流程更快地审查营销申请的时间框架。
The application is based on results from the SUPERNOVA Phase 3 trial, which demonstrated sipavibart's safety and efficacy in preventing symptomatic COVID-19 in immunocompromised patients, compared to control, in a variant landscape in which COVID-19 cases captured throughout the trial were caused by several different SARS-CoV-2 variants.
申请基于SUPERNOVA第三阶段试验结果，该试验证明了sipavibart在免疫功能受损患者中相对于对照组的症状性新冠病毒预防效果及其体内安全性和功效，在整个试验期间捕获的新冠病例涉及多种不同的SARS-CoV-2变体。
High-level results from SUPERNOVA study showed that sipavibart demonstrated a statistically significant reduction in the incidence of symptomatic COVID‐19 compared to control (tixagevimab/cilgavimab or placebo) in an immunocompromised patient population.
SUPERNOVA研究的高水平结果表明，与对照组(提咱格鲁单抗/西格鲁单抗或安慰剂)相比，sipavibart在免疫功能受损患者中症状性新冠病毒发病率显著降低。
The trial met both dual primary endpoints: relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and the relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation.
试验实现了双重主要终点：任何SARS-CoV-2变体引起的症状性新冠病毒的相对风险降低和不含F456L突变的SARS-CoV-2变体引起感染的相对风险降低。
In addition to the European Medicines Agency, AstraZeneca is in dialogue with other regulatory authorities on potential authorization or approval pathways for sipavibart.
除欧洲药品管理局外，阿斯利康与其他监管机构就sipavibart的潜在授权或批准途径进行对话。
- AstraZeneca Pulls Plug On Vaxzevria COVID-19 Vaccine Amid Surplus of Updated Vaccines.
- 阿斯利康在更新疫苗供过于求的情况下放弃了Vaxzevria COVID-19疫苗。
Price Action: AZN shares are up 0.09% at $78.06 at last check Monday.
股价：截至星期一最后一次检查，AZN股价上涨0.09%至78.06美元。
Photo via Shutterstock
图片来自shutterstock。