FDA to Review Hemispherx’s Ampligen NDA
Hemispherx Biopharma has reported that the FDA has accepted for review the company’s new drug application for Ampligen, an experimental therapeutic, to treat chronic fatigue syndrome, originally submitted in October 2007.
Hemispherx is seeking marketing approval for the first-ever treatment for chronic fatigue syndrome (CFS). At present, only supportive, symptom-based care is available for CFS patients.
The new drug application (NDA) for Ampligen is also said to be the first ever accepted for review by the FDA for systemic use of a toll-like receptor therapy to treat any condition.