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FDA Accepts New Drug Application for Antiviral Agent Peramivir
Approval decision scheduled for December (February 25)
The FDA has accepted for review a new drug application (NDA) for intravenous peramivir, which was submitted to the agency in December 2013, for the prevention of influenza.
The FDA has assigned a standard review time, resulting in a PDUFA (Prescription Drug User Fee Act) action date of December 23, 2014.
The NDA submission for peramivir included results from more than 2,700 subjects in 27 clinical trials.
The drug’s developer (BioCryst Pharmaceuticals) is preparing to make peramivir available in the U.S. during the 2014–2015 flu season, provided FDA approval is granted within that timeframe.
Peramivir is an intravenously administered investigational antiviral agent that inhibits the interactions of influenza neuraminidase, an enzyme that is critical to the spread of the influenza virus within a host. In laboratory tests, the drug has shown activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains.
Source: BioCryst Pharmaceuticals; February 25, 2014.