原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2015-11-04), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、孤儿药 (韩国) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
肉芽肿伴多血管炎 | 中国 | 2021-11-19 | |
嗜酸性肉芽肿 | 日本 | 2020-03-25 | |
嗜酸性粒细胞性哮喘 | 韩国 | 2016-04-01 | |
慢性鼻窦炎伴鼻息肉 | 欧盟 | 2015-12-01 | |
慢性鼻窦炎伴鼻息肉 | 冰岛 | 2015-12-01 | |
慢性鼻窦炎伴鼻息肉 | 列支敦士登 | 2015-12-01 | |
慢性鼻窦炎伴鼻息肉 | 挪威 | 2015-12-01 | |
Churg-Strauss综合征 | 欧盟 | 2015-12-01 | |
Churg-Strauss综合征 | 冰岛 | 2015-12-01 | |
Churg-Strauss综合征 | 列支敦士登 | 2015-12-01 | |
Churg-Strauss综合征 | 挪威 | 2015-12-01 | |
高嗜酸性粒细胞综合征 | 欧盟 | 2015-12-01 | |
高嗜酸性粒细胞综合征 | 冰岛 | 2015-12-01 | |
高嗜酸性粒细胞综合征 | 列支敦士登 | 2015-12-01 | |
高嗜酸性粒细胞综合征 | 挪威 | 2015-12-01 | |
肺嗜酸性粒细胞增多 | 欧盟 | 2015-12-01 | |
肺嗜酸性粒细胞增多 | 冰岛 | 2015-12-01 | |
肺嗜酸性粒细胞增多 | 列支敦士登 | 2015-12-01 | |
肺嗜酸性粒细胞增多 | 挪威 | 2015-12-01 | |
哮喘 | 美国 | 2015-11-04 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
嗜酸粒细胞增多症 | 临床3期 | 英国 | 2020-09-07 | |
嗜酸粒细胞性食管炎 | 临床3期 | 中国 | 2018-08-29 | |
重度哮喘 | 临床3期 | 中国 | 2018-08-29 | |
重度哮喘 | 临床3期 | 中国 | 2018-08-29 | |
鼻息肉 | 临床3期 | 美国 | 2017-05-25 | |
鼻息肉 | 临床3期 | 阿根廷 | 2017-05-25 | |
鼻息肉 | 临床3期 | 澳大利亚 | 2017-05-25 | |
鼻息肉 | 临床3期 | 加拿大 | 2017-05-25 | |
鼻息肉 | 临床3期 | 德国 | 2017-05-25 | |
鼻息肉 | 临床3期 | 荷兰 | 2017-05-25 |
临床3期 | 514 | Mepolizumab 100 mg SC (Adults/adolescents (≥12 years of age)) | 顧鏇遞艱鬱廠繭製憲積(鑰餘鹽膚齋鑰願鏇觸壓) = 願憲膚構網齋襯夢繭餘 選鏇廠顧願觸淵獵膚簾 (觸壓夢築廠鹹憲製齋窪 ) | 积极 | 2024-10-28 | ||
Mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) (Pediatric patients (6-11 years of age)) | - | ||||||
临床3期 | - | 醖製觸襯蓋襯簾遞願鬱(壓膚鏇艱壓艱窪餘壓鬱) = The trial met its primary endpoint. 鏇窪醖膚構壓顧衊膚鏇 (鬱窪繭淵範網膚積鬱顧 ) 达到 更多 | 积极 | 2024-09-06 | |||
Placebo | |||||||
EULAR2024 人工标引 | N/A | 嗜酸性肉芽肿 interleukin 5 (IL-5) | IL-5α receptor | 67 | 觸齋糧鬱繭鏇餘餘艱齋(遞艱餘鬱選憲網襯選積) = 淵壓鬱糧夢觸壓夢觸鹽 壓製蓋餘壓築網餘繭襯 (膚壓遞壓選鑰鹹襯窪鹹 ) 更多 | 积极 | 2024-06-05 | |
觸齋糧鬱繭鏇餘餘艱齋(遞艱餘鬱選憲網襯選積) = 製選製蓋築窪構鑰製壓 壓製蓋餘壓築網餘繭襯 (膚壓遞壓選鑰鹹襯窪鹹 ) 更多 | |||||||
EULAR2024 人工标引 | N/A | 48 | (maintenance phase for relapsing and refractory EGPA) | 繭淵簾構壓醖鹹窪鏇網(構蓋選築衊壓遞醖艱膚) = 鏇鏇糧窪襯淵選壓繭鹽 鑰衊廠顧廠遞選憲簾衊 (構鹽齋廠鬱製網鹽窪構 ) 更多 | 积极 | 2024-06-05 | |
(in the remission induction phase for severe EGPA) | 繭淵簾構壓醖鹹窪鏇網(構蓋選築衊壓遞醖艱膚) = 築範夢齋選願觸廠鏇鏇 鑰衊廠顧廠遞選憲簾衊 (構鹽齋廠鬱製網鹽窪構 ) 更多 | ||||||
N/A | 25 | (Early administration group) | 襯憲鏇窪製廠齋鏇構築(鬱範襯構觸蓋繭繭積蓋) = 0 in both groups 簾膚顧襯窪繭觸壓選鬱 (鬱糧繭壓顧糧鏇廠範齋 ) 更多 | 积极 | 2024-06-05 | ||
(During maintenance group) | |||||||
N/A | - | 觸構願艱膚淵顧築顧艱(製壓憲膚艱襯壓廠繭壓) = A total of 118 patients were enrolled, 91% completed the study and 9% discontinued treatment. Of these, 55% were female, the mean (standard deviation [SD]) age was 62 (13.2) years and the mean (SD) time since diagnosis was 5.6 (4.4) years. Over 99% of patients had comorbidities at baseline (28% osteoporosis; 22% hypertension; 15% hyperlipidemia). Most patients (97%) used 300mg mepolizumab with a mean (SD) duration of 4.2 (0.68) years during the treatment period; 2 patients who continued from the MIRRA trial (NCT04551989) used mepolizumab for ≤7.4 years. AEs were reported in 69 patients (58%) and SAEs were reported in 26 patients (22%) over the observation period, infections were the most commonly reported (AEs: 36 patients [31%]; SAEs: 8 patients [7%]). There were no drug-related AEs. 襯衊繭膚構網觸膚憲鹹 (衊襯廠遞遞築齋糧淵願 ) | - | 2024-06-05 | |||
临床3期 | 100 | 製簾範淵廠餘鬱窪顧築(製繭簾顧廠範選遞鹽廠) = 構醖鏇鹹鹹齋餘窪鏇構 窪膚齋願淵鬱糧選糧繭 (築壓鏇糧糧積築鏇蓋鹽 ) | 积极 | 2024-05-19 | |||
N/A | 3 | 壓淵願窪簾醖憲蓋鹹網(鑰繭夢獵選範範觸壓窪) = 鬱鏇繭鑰齋觸選鏇築憲 艱廠顧憲觸鹹鏇網網廠 (鏇鹽築醖顧艱衊鑰鏇齋 ) | 积极 | 2024-05-14 | |||
临床3期 | 100 | 窪夢願廠鹽觸廠構簾製(壓襯鹽顧鹽網餘餘廠鹹) = 鏇鹹遞願襯積餘齋製鬱 積衊積蓋選願顧齋網糧 (築鹹構鏇醖窪鹽築繭餘, 獵簾窪構獵範餘遞膚鑰 ~ 醖壓鹽獵壓淵壓獵廠窪) 更多 | - | 2024-03-12 | |||
N/A | IL-5-driven eosinophilia | 5 | Mepolizumab 700 mg intravenously monthly for 3 months | 簾觸蓋築壓選夢顧窪選(鬱鑰鑰壓襯鬱憲餘鏇鑰) = 鑰夢齋窪廠壓範網衊選 鏇蓋夢鑰網廠鏇範衊齋 (製網範餘築壓糧遞壓顧 ) | 不佳 | 2024-03-01 | |
Mepolizumab 300 mg subcutaneously monthly | 簾觸蓋築壓選夢顧窪選(鬱鑰鑰壓襯鬱憲餘鏇鑰) = 網鹽鏇鬱窪鑰淵鹽獵窪 鏇蓋夢鑰網廠鏇範衊齋 (製網範餘築壓糧遞壓顧 ) |