NEWSBRIEF: Drug manufacturer Hemispherx Biopharma Inc. has announced that the U.S. FDA has tentatively scheduled an Advisory Committee meeting to talk about Ampligen as a potential treatment for chronic fatigue syndrome.
Advisory Committees review the evidence and make recommendations. While the recommendations don't have to be followed, they usually are.
The FDA rejected Ampligen in late 2009, but at the time it offered guidance to Hemispherx about how it could improve the application. The company has submitted further data and the process is once again moving forward.
Ampligen is an immune-system modulator and anti-viral medication that's been tested against multiple illness for 30+ years without ever making it onto the market. If approved, it would be the first approved medication for chronic fatigue syndrome. The FDA is scheduled to complete its review by February 2, 2013.