The emergency use authorization of peramivir IV: a view from the manufacturer.
The 2009 H1N1 influenza pandemic prompted the US Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for the intravenous antiviral peramivir, an unapproved neuraminidase inhibitor (NAI) currently under development. Peramivir use was limited to patients for whom other NAI therapy had failed or in whom oral or inhalational drug absorption was believed to be unreliable. This introduced a patient selection bias that precluded safety and efficacy assessment. Despite the challenges and risks, there was a compelling public health need for an intravenous agent during the 2009 H1N1 pandemic.
Clinical Pharmacology, BioCryst Pharmaceuticals, Inc, Durham, North Carolina, USA. ahollister@biocryst.com
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Sheridan
D000146:Acids, Carbocyclic; D000998:Antiviral Agents / Q000627:therapeutic use*; D003517:Cyclopentanes / Q000009:adverse effects / Q000627:therapeutic use*; D017277:Drug Approval; D004345:Drug Industry; D004632:Emergency Medical Services; D006146:Guanidines / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000187:drug effects*; D007251:Influenza, Human / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
D000146:Acids, Carbocyclic; D000998:Antiviral Agents; D003517:Cyclopentanes; D006146:Guanidines; C414210:peramivir