BioCryst files FDA New Drug Application for peramivir
BioCryst, a pharmaceutical company that focuses on the development of treatment for infectious and rare diseases, is hoping to gain the first drug approval of an i.v. neuraminidase inhibitor in the U.S. against acute, uncomplicated adult influenza. Peramivir is already approved for use in Korea and Japan.
"BioCryst's first NDA filing represents an important milestone in the history of the company," President and Chief Executive Officer Jon P. Stonehouse said. "We are excited about the potential approval of peramivir as an i.v. treatment option that could benefit influenza patients in the United States. BioCryst is preparing to make peramivir available in the U.S. in time for the 2014-15 influenza season, in the event approval is received in that timeframe. We thank BARDA/HHS for enabling the successful completion of this program."
BioCryst completed a pre-NDA consultation with the FDA concerning peramivir in June of this year.
BioCryst reached an agreement regarding the requirements to complete the NDA. The peramivir NDA submission includes data from 27 clinical trials and more than 2700 subjects treated with the drug.