HHS Orders Intravenous Antiviral Flu Medication to Help Patients Hospitalized with 2009 H1N1

The U.S. Department of Health and Human Services (HHS) today (November 5) announced contract awards for up to 120,000 treatment courses of intravenous (IV) antiviral drugs to help treat hospitalized 2009 H1N1 influenza patients.

Patients hospitalized with 2009 H1N1 influenza are evaluated to determine if antiviral drugs will be useful; some patients are not able to take the drugs that are currently available as pills or liquid and may benefit from intravenous antiviral medications.

To help meet the potential need for IV medications to combat the H1N1 virus, HHS ordered 10,000 treatment courses each from BioCryst, Roche and GlaxoSmithKline, totaling $31.5 million. The contracts allow HHS to place additional orders of up to 30,000 treatment courses with each manufacturer over two years. Roche manufactures Tamiflu; GlaxoSmithKline, Relenza, and BioCryst manufactures Peramivir.

Because there are no Food and Drug Administration (FDA)-approved antiviral medications that can be administered intravenously to treat influenza, the FDA issued an emergency use authorization on Oct. 23 to allow use of intravenous peramivir, an investigational antiviral drug in the class of drugs known as neuraminidase inhibitors.

The HHS orders for intravenous oseltamivir (Tamiflu) and intravenous zanamivir (Relenza), also neuraminidase inhibitors, are predicated on FDA emergency use authorization for these medications.

FDA has not issued emergency use authorization authorizing the use of intravenous Tamiflu or Relenza. Orders for Tamiflu and Relenza are based on anticipated need of emergency use authorizations for additional IV drugs in the future. Tamiflu and Relenza) are FDA-approved in the form of pills or liquid, and studies are ongoing into the use of these two drugs intravenously for hospitalized H1N1 flu patients.

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.

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