Hemispherx Biopharma's Ampligen Rehash Unlikely to Impress FDA

Published: Sep 27, 2012

Three years after being rejected by U.S. Food and Drug Administration, Hemispherx Biopharma (HEB) is back seeking regulatory approval for Ampligen, its controversial therapy for chronic fatigue syndrome. Everyone loves a comeback story with a happy ending, but Hemispherx's second attempt won't turn out any happier than the first. FDA is likely to reject Ampligen again because Hemispherx ignored the agency's demand to run a new clinical trial in chronic fatigue syndrome. Instead, Hemipsherx has spent the past three years doing essentially nothing but re-analyzing data from the old Ampligen phase III trial completed in 2004. FDA reviewed the original study already, deeming it "lacking credible evidence of efficacy of Ampligen."

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