BioCryst Pharmaceuticals recently announced that the Peramivir NDA has been accepted for review by the FDA. The exciting news about the antiviral comes on the heels of a deadly flu season around the world, with the H1N1 virus being most commonly found. Widespread flu activity around the United States has caused alarm for practitioners and patients who were in great need of antiviral remedies in a timely manner. The Peramivir NDA will hopefully lead to an approval from the FDA, as this Neuraminidase Inhibitor will offer a novel and effectual treatment option to treat the influenza virus.
Almost twenty percent of Americans is plagued with the influenza virus annually, leading to thousands of deaths due to complications from the flu. Peramivir is already approved in both Korea and Japan, and is administered as an intravenous remedy. The ability of Peramivir to offer a large plasma concentration to the influenza infection sites of patients, as well as being a rapid antiviral agent makes this unique drug a potential boon in the future fight of influenza worldwide.
Peramivir is also efficacious at treating both strains A and B of the influenza virus, and particularly those strains that have proven to be resistant to current best in care neuraminidase inhibitors. A contract from the Biomedical Advanced Research and Development Authority, which is part of the United States Department of Health and Human Services has led to the development of Peramivir, in addition to approximately $234.8 million dollars in financial support. The FDA has declared a standard review time for Peramivir and an action date of December 23, 2014 for a Prescription Drug User Fee Act. BioCryst executives are looking forward to a successful turnout of Peramivir in time for the 2014-2015 flu seasons. Results from roughly 27 successful clinical trials which included 2,700 participants have led to a clear path to FDA approval in the near future. Laboratory tests revealed that Peramivir was a powerful opponent against several strains of the influenza virus, including H1N1, known also as the “swine flu” and the H7N9 strain.
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