The FDA has delayed once again the approval of Ampligen as the first prescription treatment for ME/CFS. The FDA’s decision was supposed to be due on May 25th. The first approval date was set to be sometime in February and was then postponed for a May decision.
Hemispherx, the manufacturer of Ampligen, says that the FDA needs another week or two because of staff scheduling changes. Is this really the hold up or is it just the FDA still not taking ME/CFS seriously? CFS has been put on the back burner by the FDA many times over the years and we (CFS patients) have felt neglected and have felt that the FDA does not consider our illness as debilitating or as serious as some other illnesses.
Not only has Ampligen been studied for treating ME/CFS but it has also been studied to treat AIDs, Hepatitis B & certain types of cancer. Side effects of Ampligen include flu-like symptoms that Hemispherx says will typically subside after the patient has used the medication over time. Ampligen is said to work by down regulating an immune pathway (RNase L), which allows the immune system to fight infection better. According to a study by Dr. Richard Podell, Ampligen increased performance of ME/CFS patients on a treadmill by 22% after patients were treated for 40 weeks.