Reversing a 2009 decision some commentators felt was potentially crippling to Hemispherx BioPharma, Ampligen’s producer, the FDA today stated they would not, after all, require a expensive 300 person study to assess Ampligen’s effectiveness in chronic fatigue syndrome (ME/CFS). (Safety concerns appear to have been taken care of.) Instead they would allow Hemispherx to use new analyses of data it’s already collected. Hemispherx must be breathing a huge sigh of relief.
A 300 person, double-blinded, placebo controlled drug trial was far beyond Hemispherx financial capacity, whose assets, Reuter’s reported, fell from 58.1 million dollars in late 2009 to just 3.6 million dollars in March of this year.
The FDA imposed some major conditions on Hemispherx in 2009 but it could have rejected the application outright. Instead it chose to give the company more and more and more time; essentially keeping the door open. With this decision, which occurred after a recent meeting between the company and the FDA, the FDA opened the door a bit wider. Reuter’s reported that Hemipherx’s stock price soared 50% on the news.
It’s not clear what circumstances prompted the FDA to change its mind but its been under fire for low rates of drug approvals over the past five years; in particular for drugs to treat chronic illnesses. With about a million people with ME/CFS in the US and government-funded studies suggesting as much as 20 billion dollars a year in economic losses, ME/CFS may be the only ‘major’ disorder without an FDA approved drug. In its report MarketWatch called ME/CFS a ‘chronic, serious debilitating disorder”. (The FDA recently agreed to a Stakeholder’s Meeting to discuss its approach to chronic fatigue syndrome.)
In March an analyst noted that although the economics of ME/CFS treatment are unclear Hemispherx could be sitting on a multi-billion dollar chronic fatigue syndrome market worldwide. Even if just a portion of ME/CFS sufferers were treated with Ampligen the potential upside for the company and its shareholders is large indeed.
Marketwatch reported that upon news of the FDA’s decision Hemispherx immediately began hiring more staff, consultants and independent contractors to prepare for the work ahead.
A 2010 study suggested Ampligen could take the place of drugs that expose some ME/CFS patients to cardiac toxicity. Other studies have shown Ampligen can significantly increase exercise tolerance.
The best drug never to get approved for ME/CFS suddenly appears to have a real chance. Hemispherx reported it will file its response in the fall of this year. The FDA typically takes up to six months to produce a decision.ar
Nothing is assured but with Hemispherx finally getting its day ‘in court’ and Rituximab trials ramping up the treatment possibilities for ME/CFS appear quite a bit brighter.
Tomorrow a blog reporting on Dr. Peterson’s take on the drug with three of his Ampligen treated patient will appear (See Dr. Peterson Talks!)
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