First approval for Hemispherx' Ampligen, in Argentina

US drugmaker Hemispherx Biopharma (NYSE MKT: HEB) has received approval of its New Drug Application (NDA) from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of rintatolimod (US trade name: Ampligen) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

The product will be marketed by GP Pharm, Hemispherx’ commercial partner in Latin America.  “We believe that rintatolimod is the first drug to receive approval for this indication anywhere in the world.  We also believe that there are no other products in the pipeline for approval, worldwide, for this debilitating disease,” the company stated.

Several post-approval activities are required to be completed before product launch, including manufacturing site inspections and reimbursement evaluation by the Health Services Authority (SSS), the central health authority in Argentina.