| FDA Allows Use of Experimental
Antiviral Drug to Treat H1N1
The U.S. Food and
Drug Administration is allowing the use of an experimental antiviral
drug to treat severe cases of H1N1 or swine flu.
The drug, Peramivir, is currently being developed by BioCryst
Pharmaceuticals Inc. and is undergoing testing required for regular
FDA approval.
The FDA issued a so-called emergency use authorization late Friday
that allows doctors to use Peramivir, which is delivered intravenously,
in certain hospitalized adult and pediatric patients with confirmed
or suspected H1N1 influenza.
A handful of doctors have already treated patients with severe
cases of H1N1 using Peramivir obtained through the agency's expanded
access rules that allow individual patients to obtain experimental
drugs if certain conditions are met. The emergency-use authorization
allows use of the drug without prior FDA approval.
The FDA said there's only limited clinical data about whether
Peramivir is safe and effective, but "based upon the totality
of scientific evidence available, it is reasonable to believe
that peramivir IV may be effective in certain patients."
The company said it is completing production of approximately
130,000 courses of peramivir and is prepared to make more, if
required.
The FDA said Peramivir should only be used in patients who have
not responded to or can't take the oral antiviral drug Tamiflu,
made by Roche or Relenza, which is an inhaled drug made by GlaxoSmithKline
PLC. Like Tamiflu and Relenza, Peramivir works by inhibiting neuraminidase,
an enzyme that's involved with the spread of the influenza virus
within the body.
The federal Centers for Disease Control and Prevention asked
the FDA to grant Peramivir emergency use to help cope with the
influenza pandemic which has killed more than 1,000 people in
the U.S. since April and hospitalized thousands more. The CDC
will control and track distribution of peramivir to hospitals.
* A
full list of h1n1 vaccine ingredients, alerts and warnings.
Reference Sources:
Foxnews.com
October 28, 2009
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