NEWSBRIEF: The decision is in, and the FDA has once again rejected the drug Ampligen (rintatolimod) for chronic fatigue syndrome, leaving this seriously debilitating illness with no approved treatments.
The FDA said the company did not provide sufficient data on either effectiveness or safety. While the rejection was expected by many, it represented a major step forward and a lot of patients, doctors and advocates were holding out hope.
However, when it comes to the drug-approval process, it's rarely "over." Ampligen's manufacturer, Hemispherx Biopharma Inc., has already said it will appeal the ruling. In the FDA's Complete Response Letter to the company, it detailed what additional data it would need in order to reconsider, which included:
- One or more additional clinical trials,
- Several non-clinical studies,
- Multiple data analyses.
Hemispherx said it believes the company did show adequate safety and efficacy data. Company officials said they plan to request an end-of-review conference with the FDA, after which it will submit an appeal.
Meanwhile, millions of people with chronic fatigue syndrome will continue to wonder whether Ampligen would work for them. While no drug helps everyone with this complex and highly variable condition, it has helped some people regain their function and quality of life.
Are you disappointed by the FDA's decision? Would you try Ampligen if it were available? Leave your comments below!