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FDA Panel Considers 1st Drug for Chronic Fatigue Syndrome
Date:12/20/2012

By Steven Reinberg
HealthDay Reporter

THURSDAY, Dec. 20 (HealthDay News) -- A U.S. Food and Drug Administration advisory committee will meet Thursday to consider approval of the first drug to treat chronic fatigue syndrome.

The experts will discuss the risks and benefits associated with the intravenous drug rintatolimod (proposed brand name Ampligen). The drug's maker, Hemispherx Biopharma of Philadelphia, failed to win the FDA's OK in 2009 because of concerns about study methodology.

Experts said they would welcome a treatment for this disabling condition that affects as many as 4 million Americans, mostly women. There is no cure, but the drug appears to reduce symptoms for some patients.

"It does seem to help at least a subset of patients significantly. For others, there isn't a significant response," said K. Kimberly McCleary, president of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America.

"This drug has been studied in chronic fatigue syndrome since the late 1980s, so it's been around for a while," McCleary added.

Dr. Nancy Klimas, professor of medicine at Nova Southeastern University College of Osteopathic Medicine in Fort Lauderdale, Fla., who is part of an ongoing trial of the drug, said some of her patients have benefitted from the drug. Now there needs to be a way to identify which patients will do well on the drug, she added.

Chronic fatigue syndrome is little understood, and Ampligen's approval would give patients some standing with their insurers, Klimas said.

"Even a single approved therapy, even if it were one I choose not to use, would be very helpful when I am arguing with insurance companies to legitimize the condition and that it is serious enough to require an intervention," Klimas said.

According to the drug company, Ampligen is a new type of drug called a nucleic acid compound, which uses specially made RNA to target a variety of disea
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