BioCryst nearly ready to submit new influenza drug to FDA
The existing contract between BioCryst and BARDA/HHS is valued at $234.8 million for the completion of the New Drug Application for peramivir. BioCryst expects the application to be ready for submission by the end of the calendar year.
Peramivir is an intravenously administered investigational drug that induces plasma prevalence at the site of influenza infection. The drug stops influenza neuraminidase interaction with enzymes, which also halts the spread of the virus within the body. In clinical trials, the vaccine was shown to be effective against H7N9 and H1N1 viral strains.
BioCryst successfully completed a preparatory meeting with the U.S. Food and Drug Administration, a preliminary step before submitting the application to the NDA. Peramivir met all FDA requirements for completing submission.
"We thank BARDA/HHS for its continued support of this program," BioCryst President and Chief Executive Officer Jon. P. Stonehouse said. "This remaining funding is what we need to get peramivir to the finish line. We are excited about the potential approval of peramivir as an i.v. treatment option that could benefit influenza patients in the United States."
Permivir has already been launched in Japan and Korea to treat patients with influenza viral infections.