Pharmaceutical Business review

HHS Announces Intravenous Antiviral Flu Medication

The US Department of Health and Human Services (HHS) has reported the contract awards for up to 120,000 treatment courses of intravenous (IV) antiviral drugs to help treat hospitalised 2009 H1N1 influenza patients.

The company said that patients hospitalised with 2009 H1N1 influenza are evaluated to determine if antiviral drugs will be useful, patients who are not able to take the drugs as pills or liquid and may benefit from intravenous antiviral medications.

HHS has ordered 10,000 treatment courses each from BioCryst, Roche and GlaxoSmithKline, for a total amount of $31.5m. 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.

FDA has issued an emergency use authoriation to allow use of intravenous Peramivir, an investigational antiviral drug. Currently there are no FDA approved antiviral medications that can be administered intravenously for influenza.

Specifically, IV Peramivir is authorised only for hospitalised adult and pediatric patients for whom therapy with an IV drug is clinically appropriate.

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, as part of a larger HHS initiative to develop promising new influenza medications and vaccines.