On October 11, 2007, Hemispherx Biopharma, Inc. announced it had filed a New Drug Application with the U.S. Food and Drug Administration (FDA) for its investigational antiviral drug ApligenR as a treatment for Chronic Fatigue Syndrome. The application includes data from four controlled clinical trials that have involved 1,200 trial subjects.
According to a press release from the New Brunswick, New Jersey-based company:
“The experimental therapeutic was originally discovered and developed at The Johns Hopkins University and thereafter licensed to Hemispherx. On December 29, 2006, the FDA received the Company’s pre-submission of pre-clinical information and assigned an NDA number. The Company will now move forward promptly with a series of scientific and medical peer-reviewed publications on the audited database contained within the NDA application.”