AIM ImmunoTech (NYSEAMERICAN:AIM) has given an update regarding Ampligen’s commercial launch in Argentina for severe Chronic Fatigue syndrome treatment.
Ampligen approved for severe CFS/ME in Argentina
Ampligen will be the first drug ever to get commercial approval for severe CFS/ME treatment in any country. This is a huge milestone for the drug for this vital regulatory step following import clearance from the regulatory agency of Argentina Admnistacion Nacional de Medicamentos Alimentos y Medica (ANMAT), which is FDA’s equivalent. The company received approval for the importation of its first commercial shipment of Ampligen vials to the country. This came after the US FDA also issued clearance to AIM ImmunoTech to export Ampligen for commercial sale to Argentina.
For now, the final step in Ampligen’s commercial launch is for ANMAT to conduct a final inspection on the drug and release test ahead of giving final approval for commencement of sales. After ANMAT gives final approval, GP Pharma will commence the distribution of Ampligen in the country. Dr. Gabriel Zeitune, the Medical Director of GP Pharma and former ANMAT Head of Evaluations of Medicines, stated that GP Pharma was working with AIM to expedite the launch of Ampligen. Zeitune added that this will offer patients and physicians a new treatment choice for CFS, thus addressing an unmet medical need.
AIM ImmunoTech met requirements for export clearance
Usually, for a drug that has not received commercial approval in the US, the FDA will require the manufacturer to meet some conditions before exporting it to the foreign country after approval. AIM had submitted all the necessary information regarding the approval processes as well as standards for the drug in Argentina for it to get export clearance. On September 19, 2019the FDA determined that the drug processes, as well as the standard for approval, were satisfactory as per the Federal Food, Drug, and Cosmetic Act section 802(b)(2).
The requirements include an expert review of the drug’s effectiveness and safety, adverse events reporting, control of labeling, and promotion of the drug as well as GMP and quality controls.