BARDA enables funding for BioCryst anti-viral agent NDA
BARDA will release funding under a current $234.8 million contract with BioCryst to enable completion of an NDA for intravenous peramivir. Peramivir is an investigational anti-viral agent that can quickly deliver high plasma concentrations to infection sites. In tests, peramivir showed activity against multiple strains of influenza, including H7N9 and pandemic H1N1 swine flu.
"We thank BARDA/(U.S. Department of Health and Human Services) for its continued support of this program," Jon Stonehouse, the president and CEO of BioCryst, 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."
BioCryst completed a pre-NDA meeting with the U.S. Food and Drug Administration regarding peramivir on June 28. The company reached an agreement with the FDA related to all requirements for a complete NDA submission. BioCryst seeks an indication for the treatment of acute uncomplicated influenza and anticipates the submission of the peramivir NDA by the close of 2013.
Peramivir works by inhibiting the interactions of influenza neuraminidase, an enzyme the virus uses when spreading within a host.