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.
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.
For more information call (919) 859-1302 or visit BioCryst.com.