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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
10/19/2018
Trade Name:
Dupixent
Generic Name or Proper Name (*):
dupilumab
Indications Studied:
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
Label Changes Summary:
*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.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Regeneron Pharmaceuticals
NNPS:
FALSE
Therapeutic Category:
Antiasthmatic
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