BioCryst Pharmaceuticals, Inc. received from the US Food and Drug Administration a fast track designation for peramivir injection in the treatment of influenza infections, including highly virulent, life-threatening strains of influenza.
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, FDA had given Biocryst approval to begin human clinical trials using injectable peramivir, states the company release.
The fast track programmes of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. In correspondence with BioCryst, the FDA said that it agrees that the use of peramivir in the proposed indication of treatment of influenza infections, including highly virulent, life-threatening strains, 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.
"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. We are initially developing the intravenous formulation of peramivir for the treatment of acutely ill influenza-infected patients and anticipate beginning Phase I clinical testing of the intravenous formulation early this quarter, at the NIH Clinical Centre in Bethesda, Maryland. In addition, we are also conducting preclinical studies with intramuscular formulations, which will be directed initially at patients with seasonal influenza infections. We are pursuing both of these development programs in close collaboration with research groups at the National Institutes of Allergy and Infectious Diseases (NIAID) at the National Institute of Health (NIH)," said Charles E. Bugg, chairman and CEO of BioCryst
BioCryst Pharmaceuticals, Inc. designs, optimises and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases, and viral infections.