通用名称

mepolizumab

儿科标签批准日期

2019/9/12 0:00:00

特定指示/秒

Add-on maintenance treatment of patients with severe asthma, and with an eosinophilic phenotype to include patients aged 6 to 11 years

标签更改摘要

- Safety and efficacy for severe asthma, and with an eosinophilic phenotype, have been established in pediatric patients aged 6 years and older; previously approved down to 12 years and older. - Use in children 6 to 11 years with severe asthma, and with an eosinophilic phenotype, is supported by evidence from adequate and well-controlled trials in adults and adolescents with additional pharmacokinetic, pharmacodynamic, and safety data in children aged 6 to 11 years. A single, open-label clinical trial was conducted in 36 children aged 6 to 11 years with severe asthma. - Based upon the pharmacokinetic data from this trial, a dose of 40 mg SC every 4 weeks was determined to have similar exposure to adults and adolescents administered a dose of 100 mg SC. - Efficacy in children aged 6 to 11 years is extrapolated from efficacy in adults and adolescents with support from pharmacokinetic analyses showing similar drug exposure levels for 40 mg administered subcutaneously every 4 weeks in children aged 6 to 11 years compared with adults and adolescents. - The safety profile and pharmacodynamic response observed in this trial for children aged 6 to 11 years were similar to that seen in adults and adolescents. - Safety and efficacy in pediatric patients aged younger than 6 years with severe asthma have not been established. - Information on dosing, and PK parameters. - Postmarketing study.

治疗类别

Antiasthmatic

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

6 YEARS - 11 YEARS

学习类型

Safety,Pharmacokinetic,Pharmacodynamic

研究设计

Open-Label,Trad PK,Pop PK

登记的患者

36

患者分析

N/A

中心的数量

13

国家数量

4

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

N/A