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Dupixent
儿科标签批准日期
2018/10/19 0:00:00
特定指示/秒
Add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and
older with an eosinophilic phenotype or with oral
corticosteroid dependent asthma
标签更改摘要
- Approved for use in adults and pediatric patients 12 years and older.
- A total of 107 adolescents aged 12 to 17 years with moderate to severe asthma were enrolled in the clinical trial.
- Not indicated for relief of acute bronchospasm or status asthmaticus.
- Safety and efficacy in pediatric patients less than 12 years with asthma have not been established.
- Safety and efficacy in pediatric patients (<18 years of age) with atopic dermatitis have not been established.
- Dupilumab exposure was higher in adolescent patients than that in adults at the respective dose level which was mainly accounted for by difference in body weight.
- The adverse event profile in adolescents was generally similar to the adults.
- Information on dosage and administration, PK parameters, clinical trial.
- New indication, new dupilumab strength.
研究年龄
12 YEARS - 17 YEARS
15 YEARS - 17 YEARS
12 YEARS - 17 YEARS
学习类型
Safety
Efficacy,Safety
Efficacy,Safety
研究设计
Open-Label
Placebo,Single-Blind
Placebo,Single-Blind,Parallel Group
西班牙裔拉美裔/拉丁裔总计
N/A
N/A
N/A
非西班牙裔/非拉丁裔总人数
N/A
N/A
N/A
美洲印第安人/阿拉斯加本地人总数
N/A
N/A
N/A