Argentina approves Hemispherx’s application for rintatolimod

Argentina's regulatory body has approved Hemispherx Biopharma's New Drug Application for the commercial sale of rintatolimod.
“In Argentina, rintatolimod (Ampligen) has just been commercially approved for the severe disabling form of ME/CFS [myalgic encephalomyelitis/chronic fatigue syndrome]. The number of patients with ME/CFS is estimated to be over 3 million worldwide, however, only a portion of these have the severe and disabling form of the disease which we are targeting with this drug,” Hemispherx CEO Tom Equels said. “Until now, there has been no commercially available effective treatment and there are no advanced clinical candidates, other than rintatolimod, that we are aware of. This commercial approval in Argentina will dramatically improve our ability to treat patients suffering from severe ME/CFS in Latin America."
Equles said Hemispherx will continue to work aggressively to clarify a path toward approval for those with severe ME/CFS in the United States, where it has Orphan Drug status must show seven years of product exclusivity.
"We are greatly encouraged by this new regulatory approval in Argentina," Equels said. "This is the most significant accomplishment to date in Hemispherx’s plan to bring our drug to severe sufferers of ME/CFS worldwide.”