NEWSBRIEF: The U.S. FDA announced that has delayed the much anticipated decision on Hemispherx Biopharma Inc.'s drug Ampligen (poly I: poly C12U) for chronic fatigue syndrome. The decision was due February 25, but now the FDA say it needs another 3 months in order to review all of the data.
If approved, Ampligen would become the first drug ever approved for chronic fatigue syndrome. Ampligen is an immume-system modulator that works by jump-starting your body's natural anti-viral pathway and regulating levels of Rnase L (a substance in your cells that attacks viruses), which can be high in people with chronic fatigue syndrome. Studies show it's more effective and has far fewer side effects than other drugs in its class. Over the past 30 years, this drug has also been studied as a possible treatment for certain types of cancer, AIDS, and avian flu.
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