Peramivir NDA Submitted for Acute Uncomplicated Influenza

BioCryst announced that it has submitted a New Drug Application (NDA) to the FDA for intravenous peramivir for the treatment of acute uncomplicated influenza in adults.

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The NDA submission for peramivir was based on results from over 2700 patients who were treated with peramivir in 27 clinical trials. Previously in June 2013, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst reached agreement with FDA regarding all requirements for a complete NDA submission.

Peramivir is a potent, intravenously administered investigational neuraminidase inhibitor that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains.

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