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.
歐洲藥品管理局(EMA)已接受阿斯利康公司(NASDAQ:AZN)的sipavibart獲得新冠疫苗預防性前瞻性應用申請，用於免疫功能受損患者的預防措施。
AstraZeneca's application for sipavibart has been accepted under an accelerated assessment procedure.
阿斯利康的sipavibart申請已經採用加速評估程序被接受。
Also Read: AstraZeneca Targets Ambitious $80B In Total Revenue By 2030 Through Pipeline Expansion.
阿斯利康通過管道擴張計劃，力爭到2030年實現800億美元的總營業收入。
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是一種正在研究的長效抗體，旨在爲免疫功能受損患者提供新冠病毒保護，這些患者通常對疫苗單獨治療反應不佳，且長期處於嚴重的新冠病毒風險中。
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的人類用藥品委員會將sipavibart評估加速，因其被認爲對公共衛生和治療創新具有重大意義。
The accelerated assessment aims to reduce the timeframe for the CHMP to review the marketing application compared to the standard procedure.
加速評估目的在於縮短比標準流程更快地審查營銷申請的時間框架。
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.
申請基於SUPERNOVA第三階段試驗結果，該試驗證明了sipavibart在免疫功能受損患者中相對於對照組的症狀性新冠病毒預防效果及其體內安全性和功效，在整個試驗期間捕獲的新冠病例涉及多種不同的SARS-CoV-2變體。
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研究的高水平結果表明，與對照組(提咱格魯單抗/西格魯單抗或安慰劑)相比，sipavibart在免疫功能受損患者中症狀性新冠病毒發病率顯著降低。
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.
試驗實現了雙重主要終點：任何SARS-CoV-2變體引起的症狀性新冠病毒的相對風險降低和不含F456L突變的SARS-CoV-2變體引起感染的相對風險降低。
In addition to the European Medicines Agency, AstraZeneca is in dialogue with other regulatory authorities on potential authorization or approval pathways for sipavibart.
除歐洲藥品管理局外，阿斯利康與其他監管機構就sipavibart的潛在授權或批准途徑進行對話。
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Price Action: AZN shares are up 0.09% at $78.06 at last check Monday.
股價：截至星期一最後一次檢查，AZN股價上漲0.09%至78.06美元。
Photo via Shutterstock
圖片來自shutterstock。
譯文內容由第三人軟體翻譯。