BioCryst files peramivir at FDA for Influenza.
BioCryst Pharmaceuticals, Inc. has announced that it has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the FDA. BioCryst is seeking an indication as the first i.v. neuraminidase inhibitor approved in the U.S. for the treatment of acute uncomplicated Influenza in adults. Peramivir is approved in Japan and Korea for the treatment of influenza.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. The peramivir NDA submission includes results in over 2700 subjects treated with peramivir in 27 clinical trials.
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