Submission based on positive 超新星 Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID‑19 in an immunocompromised patient population
澳门葡京网赌游戏’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European 药物 Agency (EMA), 免疫功能低下患者暴露前预防(预防)COVID-19.
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.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation. 与标准程序相比，加速评估旨在缩短CHMP审查MAA的时间框架.
The MAA is based on positive results from the 超新星 Phase III trial which demonstrated sipavibart’s safety and efficacy in preventing symptomatic COVID-19 in immunocompromised patients, 与对照组相比, 在不同的情况下，在试验过程中捕获的COVID-19病例是由几种不同的SARS-CoV-2变体引起的.1 超新星 is the only Phase III trial that provides efficacy data for COVID-19 pre-exposure prophylaxis exclusively in immunocompromised patients.2
教授. 保罗·卢贝，m.s.D., Ph.D., 英里每小时, 传染病学教授, 蒙彼利埃大学, 传染病和热带病科主任,
Iskra Reic, 执行副总裁, 疫苗和免疫疗法, 澳门葡京网赌游戏, 他说:“在欧洲，免疫功能低下的患者目前除了接种疫苗之外没有其他保护COVID-19的选择, 这往往不足以保护他们免受COVID-19严重后果的影响. We are pleased that the EMA has accepted this regulatory submission with an accelerated assessment procedure and will work to bring sipavibart to these highly vulnerable patients.”
超新星试验的数据将在即将召开的医学会议上公布.
除了EMA, 澳门葡京网赌游戏正在与其他监管机构就sipavibart的潜在授权或批准途径进行对话.
笔记
COVID-19和免疫功能低下人群的需求仍未得到满足
尽管世界卫生组织一年前宣布大流行已经结束, COVID-19 remains a significant problem for immunocompromised patients today and severe COVID-19 outcomes can fluctuate significantly throughout the year. 免疫功能低下的人，包括血癌患者, 接受器官移植的患者, those with end-stage renal disease requiring dialysis and those taking immunosuppressive medications typically have an insufficient immune response to COVID-19 vaccination, 使他们面临COVID-19严重后果的高风险, 即使完全接种了疫苗.3-8 发现 通知, 一个大型的真实世界证据研究, 加强正在进行的, 与普通人群相比，免疫功能低下者的COVID-19负担严重且不成比例. 尽管占了通知研究人群的4%, 约25%的COVID-19住院病例, ICU住院和死亡由免疫功能低下的患者承担, 即使在多次接种COVID-19疫苗之后.3
超新星
超新星是一个大型的III期项目, 全球, 随机, 双盲, placebo-controlled trial assessing the safety and efficacy of sipavibart 与对照组相比 (tixagevimab/cilgavimab or placebo) for the prevention of COVID-19, 为免疫功能低下患者提供唯一的COVID-19疗效数据.2
积极的高水平成果 from 超新星 showed that sipavibart demonstrated a statistically significant reduction in the incidence of symptomatic COVID‑19 与对照组相比 (tixagevimab/cilgavimab or placebo) in an immunocompromised patient population.1 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.1 超新星 demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.1
试验中的所有参与者都有免疫功能低下和/或正在接受免疫抑制治疗, 这使他们面临对疫苗接种产生不充分免疫反应的风险，并面临发展为严重COVID-19的高风险. 该研究的参与者包括患有血液恶性肿瘤等疾病的患者, 实体器官移植受者, 造血干细胞移植, 终末期肾病/透析, 并在一年内接受B细胞消耗疗法.1,2
Sipavibart was generally well-tolerated in the trial and preliminary analyses show adverse events were balanced between the control and sipavibart arms.1
Sipavibart
Sipavibart(原AZD3152)是一种针对COVID-19的研究性长效单克隆抗体(LAAB). Sipavibart was designed to provide broad and potent coverage across Omicron and ancestral viral variants by neutralising spike protein interaction with the host receptor ACE2.9
Sipavibart来源于SARS-CoV-2感染后恢复期患者捐献的b细胞. Sipavibart是用和 Evusheld 优化后具有相同的半衰期延长，降低了Fc效应函数和补体C1q结合平台.9 The reduced Fc effector function aims to minimise the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, 而不是抑制, 感染和/或疾病.
Sipavibart是由澳门葡京网赌游戏公司授权的 2022年5月来自RQ生物技术.
澳门葡京网赌游戏
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, 发展, 以及肿瘤学处方药的商业化, 罕见疾病, 和澳门葡京赌博游戏, 包括心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门葡京网赌游戏的创新药物在超过125个国家销售，并被全球数百万患者使用. 请访问 澳门葡京网赌游戏.com 并在社交媒体上关注公司 @澳门葡京网赌游戏.
参考文献
1. 澳门葡京网赌游戏. (2024年5月16日). 超新星 Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population (新闻稿). 最后访问2024年6月 http://www.AstraZeneca.com/media-centre/press-releases/2024/supernova-trial-met-covid-19-prevention-endpoint.html.
2. Clinialtrials.政府. 最后访问日期2024年6月 http://clinicaltrials.政府 /研究/ NCT05648110?词= AZD3152&排名= 3
3. Evans RA等人. Impact of COVID-19 on 免疫功能低d Populations during the Omicron Era: Insights from the Observational Population-Based 通知 Study. 《澳门葡京赌博游戏》. 2023;0(0):100747. doi: 10.1016/J.LANEPE.2023.100747
4. 杜布年代. 继续d Increased Risk of COVID-19 Hospitalisation and Death in 免疫功能低d Individuals Despite Receipt of ≥4 Vaccine Doses: Updated 2023 Results from 通知, 英国回顾性健康数据库研究. ecmid 2024海报P0409.
5. 乌龟L. Individuals with Multiple Sclerosis Are at High Risk for COVID-19 Hospitalisation and Death Despite High Rates of Vaccination: Results from the England 通知 Study. 在ecmid 2024上的口头报告.
6. Meeraus W. 严重急性呼吸道感染患者免疫功能低下的高发率, 包括SARS-CoV-2:来自多中心的结果, 检测阴性病例对照研究. [摘要][01796.
7. Meeraus W. 免疫功能低, Cancer and Other Comorbidities in Patients with Severe Acute 呼吸 Infection Testing Positive Versus Negative for SARS-CoV-2: A Post Hoc Analysis of COVIDRIVE Data from May 2021 to May 2023. #01800在ECCMID 2024.
8. Ketkar A等. Assessing the Risk and Costs of COVID-19 in 免疫功能低d Populations in a Large United States Commercial Insurance Health Plan: The EPOCH-US Study. 当前医学研究意见. 2023. 39 (8):1103-1118.
9. Francica JR, Cai Y, Diallo S，等. 1355. The SARS-CoV-2 Monoclonal Antibody AZD3152 Potently Neutralizes Historical and Emerging Variants and is Being Developed for the Prevention and Treatment of COVID-19 in High-risk Individuals. 开放论坛感染Dis. 2023年11月27日;10(增刊2):500.1192. doi: 10.1093 / ofid / ofad500.1192.