The U.S. government (department of Health and Human Services) gave BioCryst Pharmaceuticals more than $77 million to finish the Phase III clinical development of peramivir. In 2009 the department of Health and Human Services had already given about $180 million to the program. Biocryst also donated 1200 courses of treatment to the US department of Health and Human Services. The Emergency Use Authorization expired on June 23, 2010. In 2011 a phase III trial found the median durations of influenza symptoms were the same with 1 intravenous injection of peramivir against 5 days of oral oseltamivir for people with seasonal influenza virus infection.In 2012 BioCryst reported that it should halt enrollment on its study for intravenous peramivir in potentially life-threatened people after an interim analysis led trial monitors to conclude that it would be futile to continue and the trial should be terminated. The difference between peramivir and control group (oral oseltamivir) for the primary endpoint, clinical or virologic, was small. In 2013 the Biomedical Advanced Research and Development Authority (BARDA/HHS) released new funding under the current $234.8 million contract to enable completion of a New Drug Application filing for intravenous (IV) peramivir.According to a research report published in June 2011, a new variant of swine flu had emerged in Asia with a genetic adaptation (a S247N neuraminidase mutation) giving some resistance to oseltamivir and zanamivir, but no significant reduction in sensitivity to peramivir. But a H274Y virus mutation showed resistance to oseltamivir and peramivir, but not to zanamivir, and only in N1 neuraminidases.
Ultimately 3.2% (19/599) of A(H1N1)pdm09 viruses collected between 2009 and 2012 had highly reduced peramivir inhibition due to the H275Y NA mutation.BioCryst Pharmaceuticals submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for intravenous peramivir in December 2013. Peramivir (Rapivab) was approved for intravenous administration in December 2014. References
External links
"Peramivir". Drug Information Portal. U.S. National Library of Medicine. "Peramivir: Requirements for Administration under EUA". Lifehugger. Archived from the original on 2011-07-13. "CDC H1N1 Flu - Termination of the Emergency Use Authorization (EUA) of Medical Products and Devices". U.S. Centers for Disease Control and Prevention (CDC). Clinical trial number NCT00957996 for "Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza" at ClinicalTrials.gov
"A Novel Anti-viral Drug for Influenza, RAPIACTA Launch" (PDF). Shionogi & Co., Ltd. January 26, 2010. Archived from the original (PDF) on 2013-05-22.