The role of clinical pharmacology in supporting the emergency use authorization of an unapproved anti-influenza drug, peramivir.
On 23 October 2009, the commissioner of the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for peramivir for intravenous injection, an unapproved neuraminidase inhibitor used for treating certain hospitalized adult and pediatric patients infected with 2009 H1N1 influenza. This was the first EUA of an unapproved drug product. This report summarizes the critical contributions of the clinical pharmacology review team in support of the peramivir EUA.
Division of Clinical Pharmacology 4, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. vikram.arya@fda.hhs.gov
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D000146:Acids, Carbocyclic; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003517:Cyclopentanes / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004632:Emergency Medical Services / Q000331:legislation & jurisprudence; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D033161:Government Regulation; D006146:Guanidines / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006291:Health Policy; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D053118:Influenza A Virus, H1N1 Subtype / Q000187:drug effects* / Q000201:enzymology / Q000472:pathogenicity; D007251:Influenza, Human / Q000188:drug therapy* / Q000821:virology; D007275:Injections, Intravenous; D009439:Neuraminidase / Q000037:antagonists & inhibitors; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D000146:Acids, Carbocyclic; D000998:Antiviral Agents; D003517:Cyclopentanes; D004791:Enzyme Inhibitors; D006146:Guanidines; D009439:Neuraminidase; C414210:peramivir