The emergency use authorization for IV Peramivir allowed doctors to prescribe the drug to treat certain adults and children hospitalized with confirmed or suspected 2009 H1N1 infections. Specifically, IV Peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate.

To authorize emergency use of any product, the FDA commissioner must determine that in an emergency, based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life threatening disease or condition; that the known and potential benefits of the product outweigh the known and potential risks of the product in the emergency situation, and that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life threatening disease or condition.

The Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) will manage the contracts. BARDA supported the advanced development of IV Peramivir beginning in 2007 as part of a larger HHS initiative to develop promising new influenza medications and vaccines.

hhs/