通用名称

belimumab

儿科标签批准日期

2019/4/26 0:00:00

特定指示/秒

Treatment of patients with active, antibody systemic lupus erythematosus (SLE) to include children aged 5 to 17 years

标签更改摘要

- Expanded indication to pediatric patients 5 to 17 years. - Determination of efficacy in pediatric patients was based on pharmacokinetic (PK) and efficacy results from a pediatric SLE study, as well as PK exposure and extrapolation of the established efficacy of Benylsta plus standard therapy from the Phase 3 intravenous studies in adults. A randomized, double-blind, placebo-controlled, PK, efficacy, and safety study to evaluate intravenously administered Benlysta 10 mg/kg plus standard therapy compared with placebo plus standard therapy over 52 weeks was conducted in 93 pediatric patients with SLE. The proportion of pediatric patients achieving an SRI-4 response was higher in patients receiving Benlysta plus standard therapy compared with placebo plus standard therapy. - Pediatric patients receiving Benlysta plus standard therapy also had a lower risk of experiencing a severe flare compared with the placebo group. - The adverse event profile in pediatric patients was consistent with the overall population in the Phase 3 studies in adults. - Safety and effectiveness of have not been established in pediatric patients younger than 5 years of age. - Safety and effectiveness of subcutaneous administration of Benlysta have not been - established in pediatric patients younger than 18 years of age. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - Postmarketing study

治疗类别

Immunologic agent

立法类型

PREA Only

产品说明书链接

书号

1.0

研究年龄

5 YEARS - 17 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic

研究设计

Placebo,Single-Blind,Parallel Group,Trad PK

登记的患者

93

患者分析

N/A

中心的数量

29

国家数量

10

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