BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that it has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the U.S. Food & Drug Administration (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.
"BioCryst's first NDA filing represents an important milestone in the history of the company. We are excited about the potential approval of peramivir as an i.v. treatment option that could benefit influenza patients in the United States," said Jon P. Stonehouse, President & Chief Executive Officer. "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 requested and was granted a small business waiver of the application fee for the peramivir NDA filing. The waiver confirmation was submitted with the NDA filing.