NEWSBRIEF: The manufacturer of the drug Ampligen (rintatolimod) says the U.S. FDA has accepted the company's latest submission regarding the drug as a treatment for chronic fatigue syndrome.
Hemispherx Biopharma Inc. submitted Ampligen to the FDA a few years ago, and the drug was rejected in late 2009. Since then, Hemispherx has worked to fulfill the additional criteria the FDA said would be necessary for getting the drug approved.
The company says it expects to hear from the FDA in February 2013. If approved, Ampligen would become the first FDA-approved drug for chronic fatigue syndrome.
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What kind of a drug is Ampligen – antivral? antidepressant? antiseizure, or what?
I don’t know the answer to that but hopefully it’s SAFE !!!! We really don’t need any extra problem’s than what we are already dealing with.
That drug was originally designed for AIDs patients is what I’ve heard. Why they tried it on ME patients is unknown to me but for those who are SEVERELY ill with ME, many are helped. Without it, they are generally housebound or even bedbound.
Since it is very, very expensive, the average ME patient wouldn’t need to use it. I know ME patients who can’t begin to have a decent life without it. However, most don’t have access to it nor can afford it.
Ampligen is an immune modulator given in weekly infusions. Patients are currently in Phase III trials. Ampligen costs about $24,000 per year. It is estimated that Ampligen is effective for at least 15 % of patients particularly those meeting the Canadian Consensus criteria.
A stakeholder teleconference between FDA and MyalgicEncephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients and advocacy organizations will be held September 13, 2012 10:00 am – 11:30 am. Registration is required and must be received by September 7, 2012. Early registration is recommended because telephone lines will be limited to the first 50 groups and/or individuals who register.
If you would like to participate, please send your name, email
address, telephone number and affiliation information to Randi Clark
(randi.clark@fda.hhs.gov). Registrants
will receive confirmation and additional information about the
teleconference once registration has been received and accepted.
If you are unable to secure a spot many patient sites such as this one will most likely report on the results.
I participated in an ampligen double blind study from 2001 to 2002. I got the drug for the full 16 months. I had side affects, but it straightened out my immune problem. I no longer have chronic bronchitis. Ampligen is an immune modulator. At least that was what i was told. It should be approved. I still have CFS and Fibro. I am very thankful I was blessed with this drug for free.
Ampligen is indeed an immune modulator. No one knows its exact mechanism of action in ME although I believe it is linked to upregulation of innate immunity.
The recent submission is based on new peer reviewed data from a previously run study. It indicates that improvement accumulates over time beyond the original timeframe of the study. Additionally, a certain subset of patients experience greater improvement than others.
There’s a lot of anecdotal evidence online to support the above.
Approval is possible due to recent changes in the law for accelerating treatments for chronic illness especially where there is a lack of treatment options. It’s up to the FDA to ultimately decide if credible efficacy has now been proven and that the risk / benefit ratio is worthwhile for the patient population.