Peramivir is an influenza neuraminidase inhibitor that, in preclinical studies, has shown potent, broad spectrum activity against multiple strains of flu, including the H5N1 virus.
On December 22, 2005, BioCryst announced that the FDA had given the company approval to begin human clinical trials using injectable peramivir.
In correspondence with BioCryst, the FDA said that it agrees that the use of peramivir in the proposed indication meets the criterion of treating a serious life-threatening condition. Based on this conclusion, the FDA designated peramivir injection for influenza infection as a fast track product, meaning that the drug will be the subject of a faster regulatory process.
“The FDA’s decision supports our belief in the potential of peramivir as an effective therapy for the treatment of influenza, including highly virulent, life-threatening strains like those associated with avian influenza,” said Dr Charles Bugg, chairman and CEO of BioCryst.