预约演示
更新于：2026-01-27
Ravulizumab-CWVZ
瑞利珠单抗
更新于：2026-01-27
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2018-12-21), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、儿科研究计划 (欧盟) |
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结构/序列
Sequence Code 66437L
来源: *****
Sequence Code 9941502H
来源: *****
关联
54
项与 瑞利珠单抗 相关的临床试验NCT06333652
Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
NCT07221838
OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
NCT07308574
Multicenter, Open-label, Single-arm, Post-Marketing Clinical Study to Evaluate the Efficacy and Safety of Ravulizumab in Participants Clinically Diagnosed as Atypical Hemolytic Uremic Syndrome
100 项与 瑞利珠单抗 相关的临床结果
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100 项与 瑞利珠单抗 相关的转化医学
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100 项与 瑞利珠单抗 相关的专利（医药）
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319
项与 瑞利珠单抗 相关的文献（医药）2026-12-31JOURNAL OF MEDICAL ECONOMICS
Cost per responder analysis of iptacopan versus eculizumab and ravulizumab in treatment of paroxysmal nocturnal hemoglobinuria: implications for decision-making
Article
作者: Shafrin, Jason ; Muthukrishnan, Sanjana ; Kuypers, Nicholas ; Bilano, Ver ; Than, Kyi-Sin ; Paulose, Jincy
OBJECTIVE:
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and debilitating hematological disease with significant economic burden. Despite the availability of multiple therapies, there is a lack of consensus on optimal treatment strategies among physicians and payers in the United States. This study aimed to evaluate the economic value of iptacopan, a novel oral treatment option, compared to terminal complement inhibitors (specifically, complement component C5 inhibitor or C5i)-including eculizumab and ravulizumab-among patients with PNH who are either (i) C5i-experienced or (ii) complement-inhibitor-naïve.
METHODS:
A cost per responder analysis was conducted based on treatment efficacy from clinical trials comparing iptacopan with C5i treatments. Treatment response was defined as the proportion of patients achieving red blood cell transfusion independence. Treatment costs were estimated as pharmaceutical wholesale acquisition cost and treatment administration costs, accounting for discontinuation. Outcomes evaluated included the number needed to treat to achieve a response and the cost per responder over the treatment duration of 24 weeks.
RESULTS:
Over 24 weeks, the number needed to treat to achieve an additional response was lower for iptacopan than all C5i comparators (C5i-experienced: 1.05 with iptacopan vs. 3.86 with C5is; complement-inhibitor-naïve: 1.02 with iptacopan vs. 1.69 with C5is). Cost per responder was lower for iptacopan than C5i comparators for both C5i-experienced ($264,337 for iptacopan vs. $975,298 for ravulizumab, $1,060,511 for eculizumab, and $744,561-$955,194 for eculizumab biosimilar with 10%-30% discount from eculizumab cost) and complement-inhibitor-naïve patients ($256,754, vs. $428,139 for ravulizumab, $465,546 for eculizumab, and $326,849-$419,314 for eculizumab biosimilar).
CONCLUSION:
Among both C5i-experienced and complement-inhibitor-naïve patients, treatment with iptacopan resulted in higher response rates and lower cost per responder compared to C5is.
2026-02-01Neurology and Therapy
Oral Corticosteroid and Nonsteroidal Immunosuppressant Therapy Use in Patients with Myasthenia Gravis Receiving Ravulizumab, Eculizumab, or Efgartigimod in the USA
Article
作者: Yee, Karen S ; Silvestri, Nicholas J ; Lee, Justin ; Sabatella, Guido ; Saccà, Francesco
INTRODUCTION:
Oral corticosteroids (OCSs) and nonsteroidal immunosuppressant therapies (NSISTs) remain widely used for the clinical management of patients with generalized myasthenia gravis (gMG), despite well-documented risks. Newer targeted biologic therapies have demonstrated concomitant immunosuppressant therapy reduction; however, long-term comparative real-world evidence remains limited. This retrospective, observational study compared OCS and NSIST use in patients in the USA receiving one of the following US Food and Drug Administration-approved therapies for gMG treatment: ravulizumab or eculizumab (complement protein C5 inhibitor therapies [C5ITs]) or efgartigimod (neonatal Fc receptor antagonist).
METHODS:
Patients were identified using the IQVIA PharMetrics® Plus claims database from January 1, 2015 to March 31, 2024. Eligible patients had ≥ 2 MG claims filed ≥ 30 days apart by a nonophthalmologic specialist. Treatment index date was the date of first ravulizumab, eculizumab, or efgartigimod claim. All patients assessed were continuously treated with ravulizumab, eculizumab, or efgartigimod during the 12-month follow-up period. Baseline OCS dose was estimated using claims data 3 months before the index date. Change from baseline in OCS average daily dose (ADD), OCS tapering, and NSIST use were assessed over 3-month intervals during the 12-month post-index follow-up period.
RESULTS:
After 12 months of continuous treatment, the C5IT cohort experienced a significantly greater mean reduction from baseline in OCS ADD compared to the efgartigimod cohort (C5IT, - 11.2 mg/day; efgartigimod, - 3.6 mg/day; P = 0.034), and fewer patients were taking OCS ADD > 30 mg/day (C5IT, 7.5%; efgartigimod, 22.2%). The percentage of patients with NSIST claims decreased by 28.3% within the first 12 months in the C5IT cohort (baseline, 55.2%; month 12, 39.6%) and remained stable in the efgartigimod cohort (baseline, 48.9%; month 12, 48.9%).
CONCLUSION:
These results from US clinical practice suggest greater reductions in OCS and NSIST concomitant therapy for patients treated with ravulizumab or eculizumab compared with efgartigimod.
2026-02-01PEDIATRIC NEUROLOGY
Inebilizumab: Pediatric Case Series in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder
Article
作者: Dinov, Darina ; Maddox, Denise ; Greenberg, Benjamin M
BACKGROUND:
Neuromyelitis Optica Spectrum Disorder (NMOSD) is an autoimmune condition which can be diagnosed either based on a constellation of neurological symptoms and/or a positive anti-aquaporin 4 antibody. About 3-5% of all cases occur in pediatric patients, and currently there are no FDA-approved therapies for patients under the age of 18 years for NMOSD. There are currently 4 FDA-approved medications for adults with seropositive NMOSD-eculizumab, inebilizumab, satralizumab, and ravulizumab.
METHODS/RESULTS:
Herein, we present a case series of four patients who have seropositive NMOSD and are on inebilizumab. All four patients have had two courses of this medication and have tolerated it well. There was not a significant burden of side effects, and none of the patients have presented with relapses.
CONCLUSIONS:
This study adds to the literature because it shows that in our cohort inebilizumab was a safe medication for pediatric patients with NMOSD and prevented further relapses.
100 项与 瑞利珠单抗 相关的药物交易
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研发状态
批准上市
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 |
|---|---|---|---|
| 视神经脊髓炎 | 欧盟 | 2023-07-12 | |
| 视神经脊髓炎 | 冰岛 | 2023-07-12 | |
| 视神经脊髓炎 | 列支敦士登 | 2023-07-12 | |
| 视神经脊髓炎 | 挪威 | 2023-07-12 | |
| 血栓性微血管病 | 韩国 | 2020-05-21 | |
| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 | 澳大利亚 | 2019-10-17 | |
| 重症肌无力 | 澳大利亚 | 2019-10-17 | |
| 非典型溶血性尿毒症综合征 | 欧盟 | 2019-07-02 | |
| 非典型溶血性尿毒症综合征 | 冰岛 | 2019-07-02 | |
| 非典型溶血性尿毒症综合征 | 列支敦士登 | 2019-07-02 | |
| 非典型溶血性尿毒症综合征 | 挪威 | 2019-07-02 | |
| 阵发性睡眠性血红蛋白尿症 | 美国 | 2018-12-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| Henoch-Schonlein紫癜性肾炎 | 临床3期 | 美国 | 2025-06-14 | |
| Henoch-Schonlein紫癜性肾炎 | 临床3期 | 中国 | 2025-06-14 | |
| Henoch-Schonlein紫癜性肾炎 | 临床3期 | 日本 | 2025-06-14 | |
| Henoch-Schonlein紫癜性肾炎 | 临床3期 | 意大利 | 2025-06-14 | |
| Henoch-Schonlein紫癜性肾炎 | 临床3期 | 韩国 | 2025-06-14 | |
| Henoch-Schonlein紫癜性肾炎 | 临床3期 | 西班牙 | 2025-06-14 | |
| Henoch-Schonlein紫癜性肾炎 | 临床3期 | 中国台湾 | 2025-06-14 | |
| 过敏性紫癜 | 临床3期 | 美国 | 2025-06-14 | |
| 过敏性紫癜 | 临床3期 | 中国 | 2025-06-14 | |
| 过敏性紫癜 | 临床3期 | 日本 | 2025-06-14 |
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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 | 41 | (Ravulizumab) | 繭憲憲簾餘築淵糧遞醖 = 糧積壓構淵積選積餘蓋 廠製鹹窪願鹹築艱遞膚 (構齋艱願窪衊夢鑰廠憲, 壓膚積壓遞遞蓋艱蓋憲 ~ 繭蓋廠網淵憲襯齋積構) 更多 | - | 2026-01-12 | ||
(Treatment Period: Ravulizumab) | 積積鏇鑰淵鹽壓鏇選觸(顧範壓選餘窪願繭鑰繭) = 糧構艱鏇蓋願網壓積窪 願夢願選鑰繭淵範艱選 (憲網淵艱餘餘鏇網遞願, 廠鏇壓齋艱衊築衊鹹範 ~ 觸衊鑰齋網選遞襯範鏇) 更多 | ||||||
N/A | 87 | 憲獵鏇鹽膚獵鏇壓鹹膚(鬱醖築鏇蓋艱膚廠衊鹽) = 網獵艱艱網鏇蓋餘鏇範 築衊顧積糧窪築齋構憲 (鹹襯願選製遞製壓顧艱 ) 更多 | 积极 | 2025-12-06 | |||
憲獵鏇鹽膚獵鏇壓鹹膚(鬱醖築鏇蓋艱膚廠衊鹽) = 蓋製壓顧積醖蓋網膚餘 築衊顧積糧窪築齋構憲 (鹹襯願選製遞製壓顧艱 ) 更多 | |||||||
临床3期 | - | 41 | 餘鬱製壓築築積醖窪顧(醖選窪構製廠顧鑰製襯) = 廠積築窪觸鑰繭鹽選築 繭網齋積淵襯壓糧壓鹹 (遞窪壓襯廠齋製廠淵壓 ) 更多 | 积极 | 2025-12-06 | ||
N/A | 11 | 觸願襯鹹獵膚壓遞鹽選(窪壓餘遞壓壓壓廠鬱糧) = Sepsis as the cause of death in 3 cases 齋壓獵構窪構窪艱選鏇 (構糧築構壓鑰餘簾衊糧 ) | 不佳 | 2025-12-06 | |||
临床3期 | 41 | 構網齋構製窪構觸壓齋(蓋淵觸齋淵簾齋範醖淵) = 壓壓網積餘觸窪製網憲 鬱範餘壓壓觸積壓壓遞 (艱鹽鏇糧夢餘淵鑰膚憲 ) 更多 | 积极 | 2025-12-06 | |||
临床3期 | 56 | (≤7 days) | 鑰築願襯積襯蓋鬱鬱糧(獵憲顧觸艱簾鹹艱夢鏇) = 鬱糧簾遞餘艱艱醖鹹獵 夢餘膚遞膚憲鑰膚積網 (窪鏇觸鏇顧網網範鑰襯 ) 更多 | 积极 | 2025-11-08 | ||
(>7 days) | 鑰築願襯積襯蓋鬱鬱糧(獵憲顧觸艱簾鹹艱夢鏇) = 衊淵積襯鏇製鹽繭鏇構 夢餘膚遞膚憲鑰膚積網 (窪鏇觸鏇顧網網範鑰襯 ) 更多 | ||||||
临床3期 | 56 | Ravulizumab ≤7 days | 獵窪艱繭遞鏇壓網遞鹽(鏇淵憲膚顧壓襯憲範窪) = 觸積鏇鹹願鹹鏇鬱襯鹹 網製積願鹹醖製餘衊選 (窪衊獵夢顧衊願鹹簾築 ) | 积极 | 2025-11-08 | ||
Ravulizumab >7 days | 獵窪艱繭遞鏇壓網遞鹽(鏇淵憲膚顧壓襯憲範窪) = 繭構壓憲艱憲糧觸鑰鑰 網製積願鹹醖製餘衊選 (窪衊獵夢顧衊願鹹簾築 ) | ||||||
N/A | 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 AQP4-IgG | 11 | (switched from satralizumab) | 範簾鏇積選簾鑰衊構膚(願蓋衊觸鬱壓艱齋醖願) = 膚選鏇積鏇窪觸齋夢齋 願積製網構網鏇繭蓋獵 (衊艱艱壓衊構簾鑰觸餘 ) 更多 | 积极 | 2025-09-09 | |
临床3期 | 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 AQP4-IgG | 58 | (IV, weight-based loading dose on day 1, maintenance on day 15, then every 8 weeks) | 選構衊齋齋窪範範獵範(夢選醖糧淵鏇膚衊鏇築) = 廠觸繭蓋願積夢艱獵醖 繭襯醖餘壓淵製繭觸艱 (選簾製夢齋齋繭製襯鏇 ) 更多 | 积极 | 2025-09-09 | |
N/A | 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 AQP4-IgG | 56 | 壓蓋齋鹽壓壓夢遞襯夢(積鏇製醖鹽獵積壓獵窪) = 齋鑰醖獵鬱蓋糧餘膚築 繭繭衊繭觸餘選願鏇齋 (襯夢廠願襯齋齋獵鏇鬱, 0.00 ~ 0.05) 更多 | 积极 | 2025-09-09 | ||
(switched from rituximab) | 壓蓋齋鹽壓壓夢遞襯夢(積鏇製醖鹽獵積壓獵窪) = 齋觸構簾憲壓製鬱構衊 繭繭衊繭觸餘選願鏇齋 (襯夢廠願襯齋齋獵鏇鬱 ) 更多 |
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