The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza

• Published in: The New England journal of medicine Vol. 361; no. 23; pp. 2204 - 2207
• Main Authors: Birnkrant, Debra, Cox, Edward
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 03.12.2009
• Subjects: Antiviral Agents - therapeutic use; Clinical trials; Cyclopentanes - therapeutic use; Drug Approval; Drug dosages; Drug therapy; Drugs, Investigational - therapeutic use; Emergencies; Enzyme Inhibitors - therapeutic use; Guanidines - therapeutic use; Hospitalization; Humans; Influenza A Virus, H1N1 Subtype; Influenza, Human - drug therapy; Injections, Intravenous; Investigational New Drug Application; Neuraminidase - antagonists & inhibitors; Pharmaceutical industry; Swine flu; United States; United States Food and Drug Administration; United States
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMp0910479

On October 23 the FDA issued an Emergency Use Authorization for peramivir for the treatment of suspected or confirmed cases of 2009 H1N1 influenza. Drs. Debra Birnkrant and Edward Cox discuss the limited data on safety and efficacy and the criteria for emergency use of peramivir. On October 23, 2009, Food and Drug Administration (FDA) Commissioner Margaret Hamburg issued an Emergency Use Authorization (EUA) for peramivir for intravenous injection (BioCryst Pharmaceuticals). Peramivir is an unapproved investigational neuraminidase inhibitor that may be effective in treating certain hospitalized adult and pediatric patients with suspected or confirmed cases of 2009 H1N1 influenza. The EUA allows health care providers to use peramivir, subject to specified conditions. This is the first EUA that has been issued for an unapproved drug. The legal standard for the authorization of an EUA during a declared public health emergency requires a finding that it is . . .