Hemispherx Biopharma Inc. (HEB) announced that it has received approval of its New Drug Application or NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica or ANMAT for commercial sale of rintatolimod (U.S. tradename: Ampligen) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome or ME/CFS.
The product will be marketed by GP Pharm, Hemispherx's commercial partner in Latin America.
The approval was based on submission of two pivotal studies, AMP-502 and AMP-516. Safety data also included additional CFS and non-CFS studies for a total of over 800 subjects including over 100 subjects with severe CFS who received Ampligen® for one year or longer.
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