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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:  09/12/2019
 
Trade Name:  Nucala
 
Generic Name or Proper Name (*):  mepolizumab
 
Indications Studied:  Add-on maintenance treatment of patients with severe asthma, and with an eosinophilic phenotype to include patients aged 6 to 11 years
 
Label Changes Summary:  *Safety and efficacy for severe asthma, and with an eosinophilic phenotype, have been established in pediatric patients aged 6 years and older; previously approved down to 12 years and older. *Use in children 6 to 11 years with severe asthma, and with an eosinophilic phenotype, is supported by evidence from adequate and well-controlled trials in adults and adolescents with additional pharmacokinetic, pharmacodynamic, and safety data in children aged 6 to 11 years. A single, open-label clinical trial was conducted in 36 children aged 6 to 11 years with severe asthma. *Based upon the pharmacokinetic data from this trial, a dose of 40 mg SC every 4 weeks was determined to have similar exposure to adults and adolescents administered a dose of 100 mg SC. *Efficacy in children aged 6 to 11 years is extrapolated from efficacy in adults and adolescents with support from pharmacokinetic analyses showing similar drug exposure levels for 40 mg administered subcutaneously every 4 weeks in children aged 6 to 11 years compared with adults and adolescents. *The safety profile and pharmacodynamic response observed in this trial for children aged 6 to 11 years were similar to that seen in adults and adolescents. *Safety and efficacy in pediatric patients aged younger than 6 years with severe asthma have not been established. *Information on dosing, and PK parameters. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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