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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:  04/26/2019
 
Trade Name:  Benlysta
 
Generic Name or Proper Name (*):  belimumab
 
Indications Studied:  Treatment of patients with active, antibody systemic lupus erythematosus (SLE) to include children aged 5 to 17 years
 
Label Changes Summary:  *Expanded indication to pediatric patients 5 to 17 years. *Determination of efficacy in pediatric patients was based on pharmacokinetic (PK) and efficacy results from a pediatric SLE study, as well as PK exposure and extrapolation of the established efficacy of Benylsta plus standard therapy from the Phase 3 intravenous studies in adults. A randomized, double-blind, placebo-controlled, PK, efficacy, and safety study to evaluate intravenously administered Benlysta 10 mg/kg plus standard therapy compared with placebo plus standard therapy over 52 weeks was conducted in 93 pediatric patients with SLE. The proportion of pediatric patients achieving an SRI-4 response was higher in patients receiving Benlysta plus standard therapy compared with placebo plus standard therapy. *Pediatric patients receiving Benlysta plus standard therapy also had a lower risk of experiencing a severe flare compared with the placebo group. *The adverse event profile in pediatric patients was consistent with the overall population in the Phase 3 studies in adults. *Safety and effectiveness of have not been established in pediatric patients younger than 5 years of age. *Safety and effectiveness of subcutaneous administration of Benlysta have not been established in pediatric patients younger than 18 years of age. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study.
 
Product Labeling:  [INVALID]  Opens a new window
 
PREA(P):  P
 
Sponsor:  Human Genome Sciences, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Immunosuppressant
 
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