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WASHINGTON(BUSINESS WIRE)
The U.S. Department of Health and Human Services (HHS) today 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 needof 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.
For more information on the emergency use of IV Peramivir authorized by
FDA, including information for health care providers on patient
eligibility, see http://www.cdc.gov/h1n1flu/eua/.
Healthcare providers can also call 1-800-CDC-INFO (1-800-232-4636).
Additional information about BARDA contracts is available at https://www.medicalcountermeasures.gov/announcements.aspx.
Note: All HHS press releases, fact sheets and other press materials are
available at http://www.hhs.gov/news.
HHS Press Office
202-690-6343
Source: U.S. Department of Health and Human Services
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