通用名称

dupilumab

儿科标签批准日期

2021/10/20 0:00:00

特定指示/秒

Add-on maintenance treatment of pediatric patients 6 years and older with moderate-to-severe asthma

标签更改摘要

- Safety and effectiveness of DUPIXENT for an add-on maintenance treatment in patients with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma have been established in pediatric patients 6 years and older; previously approved in pediatric patients ages 12 years and older. - Use for this indication is supported by evidence from adequate and well-controlled studies in adult and pediatric patients 6 years and older. - A total of 408 pediatric patients aged 6 to 11 years with moderate-to-severe asthma were enrolled in AS Trial 4. Improvement in asthma exacerbations and lung function were demonstrated. The effectiveness in patients aged 6 to 11 years old with body weight 15 to <30 kg was extrapolated from efficacy of 100 mg Q2W in AS Trial 4 with support from population pharmacokinetic analyses showing higher drug exposure levels with 300 mg Q4W. Patients who completed the treatment period of the AS Trial 4 study could participate in the open-label extension study (AS Trial 5). Eighteen patients (≥15 to <30 kg) out of 365 patients were exposed to 300 mg Q4W in this study, and the safety profile in these eighteen patients was consistent with that seen in AS Trial 4. Additional safety for DUPIXENT 300 mg Q4W is based upon available safety information from the pediatric atopic dermatitis indication. - Safety and effectiveness in pediatric patients <6 years of age with asthma have not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trial. - Postmarketing study.

治疗类别

Antiasthmatic

立法类型

PREA Only

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