Hemispherx Biopharma Inc. received approval of its new drug application for commercial sale of Ampligen for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome in the Argentine Republic.
According to a company press release, the drug is the first to receive approval for this indication in the world. The approval was based on the submission of two pivotal studies and additional chronic fatigue syndrome and non-chronic fatigue syndrome studies for a total of more than 800 patients, including 100 patients who received Ampligen (rintatolimod) for 1 year or longer. The release also noted Hemispherx and GP Pharm are working to expand approval of rintatolimod to additional countries, with a focus on Latin America.
“This commercial approval in Argentina will dramatically improve our ability to treat patients suffering from severe [myalgic encephalomyelitis/chronic fatigue syndrome] ME/CFS in Latin America,” Tom Equels, chief executive officer of Hemispherx, said in the release. “We continue to work aggressively to clarify a path toward approval for those with severe ME/CFS in the United States, where we have orphan drug status, and therefore 7 years of product exclusivity upon approval. We are greatly encouraged by this new regulatory approval in Argentina. This is the most significant accomplishment to date in Hemispherx’s plan to bring our drug to severe sufferers of ME/CFS worldwide.”