The FDA rejected Ampligen in December 2009. In its complete response letter to Hemispherx, the agency outlined several steps by which the company could once again present the drug for approval. A key step was to complete at least one more clinical study including 300 or more patients.
Last March, Hemispherx instead published new data analysis from a previous trial showing that some, among other things, that participants taking Ampligen made improvements in exercise tolerance, which is one of the major problems for people with ME/CFS.
That analysis lead to a meeting between the company and the FDA on whether this new information would be sufficient to resubmit the drug under the original New Drug Application.
The company now says it will resubmit Ampligen before the end of September and the FDA will put it on a six-month review cycle. That means we should have a decision by the end of March.
Currently, no drugs are FDA approved for treating ME/CFS.
Ampligen is an immune-system modulator that's been in development for decades but has yet to be approved for any use.
- Learn more: Ampligen for Chronic Fatigue Syndrome.