通用名称

evolocumab

儿科标签批准日期

2021/9/24 0:00:00

特定指示/秒

• As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients 10 years and older with HeFH, to reduce LDL-C • As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C

标签更改摘要

- Safety and effectiveness of Repatha in combination with diet and other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients aged 10 years and older. - Use for this indication is supported by evidence from an adequate and well-controlled trial in adults and pediatric patients aged 13 years and older with HoFH (including 7 pediatric patients treated with REPATHA) and from open-label studies which included an additional 19 pediatric patients aged 11 years and older with HoFH not previously treated with REPATHA. - Safety and effectiveness as an adjunct to diet and other LDL-C-lowering therapies for the treatment of HeFH have been established in pediatric patients aged 10 years and older. - Use for this indication is based on data from a 24-week, randomized, placebo-controlled, double-blind trial in pediatric patients with HeFH. In the trial, 104 patients received REPATHA 420 mg subcutaneously once monthly and 53 patients received placebo; 39 patients (25%) were 10 to 11 years of age. - Safety and effectiveness have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia. - Information on dosing, adverse reactions, and clinical trials. - Postmarketing study.

治疗类别

Lipid Altering Agents

立法类型

PREA Only

产品说明书链接