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Hemispherx Vows To Fight FDA’s Second Rejection Of Ampligen

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In a “complete response” letter, FDA requested at least one new clinical trial, along with nonclinical studies and numerous data analyses, before approval of the chronic fatigue syndrome drug. Hemispherx continues to assert the existing data support approval and plans an appeal to FDA’s Office of New Drugs.

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Chronic fatigue drug received two FDA complete response letters, but company now agrees to additional study, new CEO says. Firm hopes Argentine approval also bodes well.

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December’s Arthritis Advisory Committee review of Hemispherx’s drug provided FDA with the first public opportunity to explain in detail why the chronic fatigue syndrome drug, in development for almost 25 years, has not passed regulatory muster to date.

FDA Takes Dim View Of Ampligen For Chronic Fatigue Syndrome

In review documents released ahead of a Dec. 20 advisory committee meeting, agency questions the validity of Hemispherx’s post-hoc efficacy analyses and raises concerns about adverse events and the reliability of the safety data.

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