BioCryst Pharmaceuticals, Inc has been informed by its partner, Green Cross Corp., that Green Cross has filed a New Drug Application (NDA) in South Korea to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza.
"Green Cross has rapidly prepared their regulatory filing, the second application of what we hope will be many for marketing approvals of peramivir," said Jon P Stonehouse, president and chief executive officer of BioCryst. "BioCryst is focused on completing the development of i.v. peramivir as a treatment for hospitalized patients with seasonal influenza in the US. Additionally, we continue to work with other governments and our global network of partners to provide i.v. peramivir as a treatment option in the event of another wave of severe influenza during the current H1N1 pandemic, and on an ongoing basis for future influenza seasons through traditional regulatory approvals."
Peramivir is a potent, intravenously administered anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection.
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases.