AIM ImmunoTech Inc (NYSEAMERICAN:AIM) has received approval from Argentinian regulators to import its myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) drug Ampligen.
The company recently got a nod from the US Food and Drug Administration to export the drug to Argentina for commercial sale.
The Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT), the country’s FDA equivalent, is the federal body allowing Ampligen to begin importing commercial grade vials of the drug.
READ: AIM ImmunoTech files provisional patent application for Ampligen as treatment for COVID-19 induced fatigue
From here, ANMAT will conduct a final inspection and drug release tests and determine whether to grant final approval. Assuming it does so, distribution of the drug will be carried out by Ampligen’s local representative GP Pharma.
“Ampligen is the only drug approved for severe CFS anywhere in the world,” CEO Tom Equels said in a statement. “In parallel, we continue to seek regulatory approval for commercial sales to treat ME/CFS patients in the United States. As we enter the final phase of our commercial launch of Ampligen in Argentina, we also intend to investigate how Ampligen can be of service should there be a surge of COVID-19 induced chronic fatigue cases worldwide by targeting COVID-19 induced severe chronic fatigue in early onset patients."
There’s reason to suggest that Ampligen may also play a role in treating patients who have ME/CFS as a result of the coronavirus. The 2002-03 SARS epidemic, for instance, resulted in high rates of ME/CFS among survivors, with one study noting that 40% of patients reported a fatigue problem.
"Over the past 30 years of utilizing Ampligen in FDA-authorized clinical trials for patients with Chronic Fatigue Syndrome, the drug has been found to be generally well-tolerated,” said Dan Peterson, head of Sierra Internal Medicine.“Based on my experience as a principal investigator in Ampligen trials, I believe that there may be a greater response rate in patients who receive the drug earlier in the disease, after meeting the CFS/ME diagnostic criteria.
“Therefore, it is possible that tests of Ampligen in patients who have, or have recently had, COVID-19 infection may provide further insight into the pathogenesis of both COVID-19 and CFS/ME and may lead to important therapeutic approaches that alter the course of COVID-19-induced chronic fatigue morbidity."
AIM ImmunoTech is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers.
Contact Andrew Kessel at [email protected]
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