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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:  04/07/2008
Trade Name:  Orencia
Generic Name or Proper Name (*):  abatacept
Indications Studied:  Moderate to severe polyarticular juvenile idiopathic arthritis
Label Changes Summary:  * Indicated for reducing signs and symptoms in pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) ages 6 years and older. * The safety and effectiveness in pediatric patients < 6 years of age and in pediatric patients for uses other than JIA have not been established * Abatacept was studied in 190 patients 6 - 17 years with polyarticular JIA. * AEs were generally similar to those seen in adults. Overall frequency of adverse events in the 4-month, lead-in, open-label period of the study was 70%; infections occurred at a frequency of 36%. A total of 6 serious adverse events were reported during the initial 4 months of treatment with abatacept. * Information on dosing, PK, immunogenicity, immunization needs, AEs, and clinical study * New indication
Sponsor:  Bristol-Myers Squibb
Therapeutic Category:  Anti-inflammatory