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FDA accepts antiviral drug AmpligenR for review as first-ever ME/CFS (‘chronic fatigue syndrome’) therapeutic

  [ 103 votes ]   [ 5 Comments ]
www.ProHealth.com • July 8, 2008


July 8 – After 30 years in development and testing, the experimental “antiviral/immune modulatory” drug AmpligenR has been accepted by the FDA for review as potentially the first prescription drug approved in the U.S. for treatment of ME/CFS – specifically for certain patients with severe ME/CFS.

Delivered intravenously, typically twice weekly over a year or more, AmpligenR (AMPLified GENetic activity) has been available in Belgium and Canada for ME/CFS and HIV treatment since 1996.

AmpligenR (polyI:polyC12U) - still allowed only in specific clinical trial settings conducted under U.S. governmental authorization - is termed “a nucleic acid drug,” designed to “modulate” the body’s immune system. Its mechanism of action in ME/CFS “is not entirely clear,” but it is thought to act on two enzyme systems so as to help the immune system destroy viral RNA and speed the death of virus-affected cells. In particular it may “downregulate” an anti-viral pathway which research suggests has become “upregulated” in certain ME/CFS patients (the 2-5 Synthetase/RNase L anti-viral pathway).

The drug’s maker – Philadelphia-based Hemispherx Biopharma, submitted a New Drug Application to the FDA in 2007, and had been asked to answer a series of questions. The FDA’s acceptance of the drug for safety/efficacy review was based on receipt of the requested data. The maker reportedly suggests it is also researching oral delivery of the drug.

A "Who's-Who" of the world’s leading ME/CFS specialists have participated in AmpligenR trials over the years.




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Article Comments Post a Comment

Hooray!
Posted by: sick~kitty
Jul 9, 2008
If I remember rightly, this drug is a miracle treatment for a very few. I would love to find out if I could be one of them.
Reply Reply

 
GREAT ARTICLE
Posted by: DIAMOND_567
Aug 13, 2008
LOVE IT AND AM TRYING TO GET MY DR. TO PUT ME ON IT. NO ONE IS AWARE OF IT AND SO ALL IS IN THE DARK.

WE ARE LIKE GUINEA PIGS TRYING TO FIND THE INFORMATION FOR OURSELVES AND THEN FIND SOMEONE TO TREAT US.

I FIND IT SAD. THANKS FOR THIS, I WILL BRING IT TO THE DR. ALL HELPS.

DIAMOND

 


the drug approval process-slow as molasses
Posted by: outofstep
Jul 10, 2008
Hurry up and APPROVE this drug FDA! It's been around since the 70s, you know it works and we've been waiting long enough!!!
Reply Reply
 
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