Fri Oct 23, 10:28 PM
By Helen Branswell, Medical Reporter, The Canadian Press
TORONTO - Drug regulators in the United States have issued an emergency use authoritization for a new flu drug, the first new influenza antiviral in years.
The Food and Drug Administration announced Friday that it had granted the emergency use approval for peramivir at the request of the Centers for Disease Control.
The drug, made by BioCryst Pharmaceuticals of Birmingham, Ala., is given intravenously and is the only one flu drug administered through this method.
The approval allows use of the drug in hospitalized adults and children who can't take or aren't responding to other flu medications.
"The FDA has reviewed the available scientific data and has concluded that the criteria for authorizing the emergency use of IV peramivir have been met," the agency said in a statement.
Peramivir is a neuraminidase inhibitor, a drug that stops replication of flu viruses in the body by blocking the virus's ability to spread from infected cells to uninfected ones. It is in the same class of drugs at the two key flu antivirals, Tamiflu and Relenza.
Experts have been calling for years for the development of an IV flu drug for use in severely ill hospitalized patients who can't take the existing flu medications which are either in pill form or inhaled powder.
The need for this kind of a drug was deemed critical when cases of H5N1 avian flu were occurring more frequently, because that virus renders most people who contract it gravely ill.
But neither Roche, which makes Tamiflu, nor GlaxoSmithKline, which makes Relenza, have been willing to bring intravenous formulations of their drugs through the expensive regulatory approvals process.
Testing the drugs in ways that meet the standards of drug regulators has proven to be a challenge and the market for IV flu drugs would not be large or lucrative during regular flu seasons.
BioCryst has received substantial funding from the U.S. government to develop the drug as part of U.S. pandemic preparedness efforts. In 2007, the Department of Health and Human Services awarded BioCryst a $102.6 million, four-year contract to pursue development of the drug.
The approval came the same day U.S. officials admitted to significant delays in delivery of pandemic vaccine. The head of the CDC, Dr. Tom Frieden, admitted vaccine may arrive "too late for many."
While the emergency use authorization only covers the United States, Toronto-based infectious disease expert Dr. Allison McGeer said the drug will likely be available to Canadian physicians too, if the company has adequate supplies.
She said Health Canada has a good emergency release system for compassionate use of drugs not available in Canada.
"In order to get compassionate release anything, the company and Health Canada have to agree that it's a reasonable thing to do," said McGeer, who is head of infection control at Mount Sinai Hospital.
"And my guess is that in real situations where somebody cannot for some reason take an oral (flu) drug, that the company and Health Canada will agree to that.... It will depend on availability of supply."