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U.S. Department of Health and Human Services

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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Regeneron Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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