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

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