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Hemispherx files NDA for Ampligen

Hemispherx Biopharma has filed a new drug application with the FDA for its experimental therapeutic Ampligen to treat chronic fatigue syndrome. The company is also moving forward as planned with filings in countries outside the US.

Centers for Disease Control (CDC) refers to chronic fatigue syndrome (CFS) as a ‘disabling disease, as disabling as other severe chronic conditions like multiple sclerosis, COPD (chronic obstructive pulmonary disease) and rheumatoid arthritis’ in its ongoing public awareness campaign. The condition may also be associated with early death due to secondary depression/suicide and cancer.

William Carter, CEO and chairman, said: “The comprehensive data package being submitted has been possible because of the guidance and scientific support of the FDA, the CDC and CFS advisory committees to both the government and the private sector. Our profound gratitude goes out to the teams of independent clinical investigators around the country and, especially, to the individuals afflicted with CFS who supplied the courage and will to sustain the research, clinical and regulatory communities in their continuing search for better understanding and management of CFS.”