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Vax crisis could spur swift peramivir approval

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There's been a considerable amount of speculation about which of the new flu vaccine and antiviral technologies now in the clinic will benefit from the swine flu outbreak and the outcry it has provoked for better medicines. Most of that speculation has centered on future pandemics--but BioCryst may not have to wait that long.

While HHS Secretary Kathleen Sebelius was being grilled about shortages of vaccines and antivirals, she voiced a strong desire to see the intravenous formulation of BioCryst's antiviral peramivir approved quickly. The U.S. is facing an outbreak that White House science advisers believe could leave 150,000 to 300,000 people hospitalized in intensive care units. And there is not a large enough supply of intravenous Tamiflu and Relenza to satisfy demand.

"There could be a lot of people looking for the IV antiviral," noted Senator Joe Lieberman during yesterday's hearings. And Sebelius indicated that an approval for the use of intravenous peramivir could come in a matter of days. BioCryst recently began two late-stage trials of intravenous peramivir. Two years ago the U.S. government handed BioCryst a $102 million contract to develop the therapy. There have been about 20 cases of compassionate use of peramivir for hospitalized patients, but doctors want a reliable supply now.

"This will be a life and death decision," Lieberman told Sebelius. 

Sebelius' reply: "Yes, senator, all of that is correct and it is - it is imminent."

- read the story from Reuters

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And while the government is messing around trying to decide whether or not to approve this drug, I have a friend in hospital with a severe case of H1N1, a complication of being in an ER with a ruptured appendix and surrounded by people coughing the virus everywhere. Her doctor spent four hours filling out the paperwork to ask to use it, it's a life and death decision every hour she does not receive treatment, and there is no decision made yet. Nobody in Washington or the FDA seems to understand there are poeple dying around them.

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