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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:  03/26/2020
 
Trade Name:  Taltz
 
Generic Name or Proper Name (*):  ixekizumab
 
Indications Studied:  Moderate-to-severe plaque psoriasis
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients 6 years to less than 18 years with moderate-to-severe plaque psoriasis. *Safety and effectiveness in other pediatric indications and for pediatric patients less than 6 years of age have not been established. *In the clinical trial, Crohn's disease occurred at a greater frequency in the treatment group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn's disease occurred in a total of 4 Talkz treated patients (2.0%) in the clinical trial. *Safety profile was similar to those observed in adults with plaque psoriasis with the exception of the frequencies of conjunctivitis (2.6%), influenza (1.7%), and urticaria (1.7%). *Information on dosing, adverse reactions, PK parameters and clinical trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Eli Lilly
 
NNPS:  FALSE
 
Therapeutic Category:  Humanized interleukin-17A antagonist
 
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