FDAnews
www.fdanews.com/articles/82717-biocryst-files-application-for-injectable-peramivir

BIOCRYST FILES APPLICATION FOR INJECTABLE PERAMIVIR

November 28, 2005

BioCryst Pharmaceuticals has submitted an investigational new drug application to the FDA for injectable formulations of peramivir, the company's influenza neuraminidase inhibitor. In preclinical studies, peramivir has shown potent, broad-spectrum activity against multiple strains of flu, including the H5N1 virus.

Peramivir is part of a class of antiviral agents that work by inhibiting viral neuraminidase, an enzyme essential for the influenza virus to replicate and infect its hosts. In preclinical tests, peramivir has been shown to be a potent and selective inhibitor of influenza A and B neuraminidases and the compound was generally well-tolerated in extensive clinical studies as an oral formulation. To date, both intravenous and intramuscular formulations of peramivir have been evaluated in preclinical animal models with success.