更新于：2024-07-01
Romlusevimab
罗米司韦单抗
更新于：2024-07-01
概要
基本信息
药物类型 单克隆抗体 |
别名 BRII-198、BRII198 |
作用机制 SARS-CoV-2 S protein抑制剂(冠状病毒刺突糖蛋白抑制剂) |
在研适应症 |
非在研适应症- |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-12-08), |
最高研发阶段(中国)批准上市 |
特殊审评附条件批准 (中国) |
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序列信息
Sequence Code 651435872H
来源: *****
Sequence Code 651435873L
来源: *****
关联
7
项与 罗米司韦单抗 相关的临床试验A Phase 2 Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients
A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients
A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers
100 项与 罗米司韦单抗 相关的临床结果
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100 项与 罗米司韦单抗 相关的转化医学
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100 项与 罗米司韦单抗 相关的专利（医药）
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13
项与 罗米司韦单抗 相关的文献（医药）2023-09-01International journal of biological macromolecules
Potent antibodies against immune invasive SARS-CoV-2 Omicron subvariants
Review
作者: Zhou, Hao ; Wang, Yang ; Wang, Lidong
The development of neutralizing antibodies (nAbs) is an important strategy to tackle the Omicron variant. Omicron N-terminal domain (NTD) mutations including A67V, G142D, and N212I alter the antigenic structure, and mutations in the spike (S) receptor binding domain (RBD), such as N501Y, R346K, and T478K enhance affinity between the RBD and angiotensin-converting enzyme 2 (ACE2), thus conferring Omicron powerful immune evasion. Most nAbs (COV2-2130, ZCB11, REGN10933) and combinations of nAbs (COV2-2196 + COV2-2130, REGN10933 + REGN10987, Brii-196 + Brii-198) have either greatly reduced or lost their neutralizing ability against Omicron, but several nAbs such as SA55, SA58, S309, LY-CoV1404 are still effective in neutralizing most Omicron subvariants. This paper focuses on Omicron subvariants mutations and mechanisms of current therapeutic antibodies that remain efficacious against Omicron subvariants, which will guide us in exploring a new generation of broad nAbs as key therapeutics to tackle SARS-CoV-2 and accelerate the exploration of novel clinical antiviral reagents.
2023-06-05Intensive care research
Effect of the Timing of Amubarvimab/Romlusevimab (BRII-196/198) Administration on Progression to Severe Disease in Elderly Patients with COVID-19 Infection: A Retrospective Cohort Study.
Article
作者: Zhang, Shuo ; Zheng, Ruiqiang ; Si, Shujie ; Xu, Yonghao ; Xi, Yin ; Deng, Xilong ; Liu, Ying ; Yang, Yi ; Li, Manshu ; Wang, Ya ; Tang, Xiaoping ; Xie, Jianfeng ; Wang, Gang ; Liu, Xiaoqing ; Zhou, Liang
Objective:
Early intervention with neutralizing antibodies is considered to be effective in preventing disease progression in patients with mild to moderate COVID-19 infection. Elderly patients are the most susceptible and at a higher risk of COVID-19 infection. The present study aimed to assess the necessity and possible clinical benefits of the early administration of Amubarvimab/Romlusevimab (BRII-196/198) in the elderly population.
Methods:
The present study was designed as a retrospective, multi-center cohort study conducted with 90 COVID-19 patients aged over 60, who were divided into two groups based on the timing of the administration of BRII-196/198 (administration at ≤ 3 days or > 3 days from the onset of infection symptoms).
Results:
The ≤ 3 days group exhibited a greater positive effect (HR 5.94, 95% CI, 1.42-24.83; P < 0.01), with only 2 patients among 21 patients (9.52%) exhibiting disease progression, compared to the 31 patients among the 69 patients (44.93%) of the > 3 days group who exhibited disease progression. The multivariate Cox regression analysis revealed low flow oxygen support prior to BRII-196/198 administration (HR 3.53, 95% CI 1.42-8.77, P < 0.01) and PLT class (HR 3.68, 95% CI 1.37-9.91, P < 0.01) as independent predictors of disease progression.
Conclusions:
In elderly patients with mild or moderate COVID-19 disease, who do not require oxygen support and had the risk factors for disease progression to severe COVID-19 disease, the administration of BRII-196/198 within 3 days resulted in a beneficial trend in terms of preventing disease progression.
2023-05-01Annals of internal medicine
Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19.
Article
作者: Choudhary, Manish C ; Li, Jonathan Z ; Hoover, Keila ; Eron, Joseph J ; Pinilla, Mauricio ; Ritz, Justin ; Currier, Judith S ; D'Andrea Nores, Ulises ; Evering, Teresa H ; Ma, Ji ; Zhu, Qing ; Zhong, Lijie ; Moser, Carlee ; Chew, Kara W ; Bender Ignacio, Rachel ; Deo, Rinki ; Fletcher, Courtney V ; Fischer, William A ; Mocherla, Bharat ; Daar, Eric S ; Hughes, Michael D ; Wohl, David Alain ; Smith, Davey ; Giganti, Mark J ; Margolis, David ; Javan, Arzhang Cyrus ; Yan, Li
BACKGROUND:
Development of safe and effective SARS-CoV-2 therapeutics is a high priority. Amubarvimab and romlusevimab are noncompeting anti-SARS-CoV-2 monoclonal antibodies with an extended half-life.
OBJECTIVE:
To assess the safety and efficacy of amubarvimab plus romlusevimab.
DESIGN:
Randomized, placebo-controlled, phase 2 and 3 platform trial. (ClinicalTrials.gov: NCT04518410).
SETTING:
Nonhospitalized patients with COVID-19 in the United States, Brazil, South Africa, Mexico, Argentina, and the Philippines.
PATIENTS:
Adults within 10 days onset of symptomatic SARS-CoV-2 infection who are at high risk for clinical progression.
INTERVENTION:
Combination of monoclonal antibodies amubarvimab plus romlusevimab or placebo.
MEASUREMENTS:
Nasopharyngeal and anterior nasal swabs for SARS-CoV-2, COVID-19 symptoms, safety, and progression to hospitalization or death.
RESULTS:
Eight-hundred and seven participants who initiated the study intervention were included in the phase 3 analysis. Median age was 49 years (quartiles, 39 to 58); 51% were female, 18% were Black, and 50% were Hispanic or Latino. Median time from symptom onset at study entry was 6 days (quartiles, 4 to 7). Hospitalizations and/or death occurred in 9 (2.3%) participants in the amubarvimab plus romlusevimab group compared with 44 (10.7%) in the placebo group, with an estimated 79% reduction in events (P < 0.001). This reduction was similar between participants with 5 or less and more than 5 days of symptoms at study entry. Grade 3 or higher treatment-emergent adverse events through day 28 were seen less frequently among participants randomly assigned to amubarvimab plus romlusevimab (7.3%) than placebo (16.1%) (P < 0.001), with no severe infusion reactions or drug-related serious adverse events.
LIMITATION:
The study population was mostly unvaccinated against COVID-19 and enrolled before the spread of Omicron variants and subvariants.
CONCLUSION:
Amubarvimab plus romlusevimab was safe and significantly reduced the risk for hospitalization and/or death among nonhospitalized adults with mild to moderate SARS-CoV-2 infection at high risk for progression to severe disease.
PRIMARY FUNDING SOURCE:
National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
100 项与 罗米司韦单抗 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 新型冠状病毒感染 | 中国 | 2021-12-08 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 353 | (BRII-196/BRII-198 Plus SOC) | 網糧願選艱製廠窪憲膚(鹹淵遞鬱淵餘艱艱衊廠) = 鏇築選糧醖網鑰齋鬱艱 淵鹽鹹鏇醖選壓願網廠 (糧鹽衊積顧餘憲選積製, 鏇築鹹窪鏇網製網積衊 ~ 壓淵選獵夢夢顧鏇鑰鏇) 更多 | - | 2024-02-05 | ||
Placebo+Remdesivir (Placebo Plus SOC) | 網糧願選艱製廠窪憲膚(鹹淵遞鬱淵餘艱艱衊廠) = 築淵鹹鏇廠繭醖夢鹽憲 淵鹽鹹鏇醖選壓願網廠 (糧鹽衊積顧餘憲選積製, 餘糧窪網製艱鑰繭鑰製 ~ 繭廠網廠築製觸蓋選淵) 更多 | ||||||
临床3期 | 837 | 蓋糧鑰蓋觸製糧顧製構(鑰遞艱範艱蓋鬱廠遞夢) = 範衊淵夢糧餘鹽襯窪簾 艱簾憲廠壓衊積蓋鏇繭 (鬱觸繭艱憲淵簾壓鹹網 ) 更多 | 积极 | 2021-08-24 | |||
Placebo | 憲衊壓艱襯壓淵壓製範(遞築襯壓齋壓鏇鏇餘淵) = 壓顧積願遞廠膚網餘網 遞壓醖鏇夢範簾網築糧 (艱遞築壓衊鑰窪製鬱顧 ) 更多 |
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