Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, says, "This product offers a new alternative therapy for several types of infections associated with Candida."
He continues, "It is a helpful addition to the available anti-fungal medications that can be used in the treatment of these potentially serious fungal conditions."
Eraxis (anidulafungin) is a new molecular entity that has never been marketed in the United States.
It an anti-fungal drug that is administered intravenously, and is used to treat Candida infections in the esophagus, blood stream. It can also treat other forms of infections such as abdominal abscesses and peritonitis (inflammation of the lining of the abdominal cavity).
The FDA evaluated the safety and efficacy of Eraxis in clinical studies. They found the drug to be safe and effective in the treatment of esophageal candidiasis, candidemia, and other Candida infections.
Patients generally tolerated Eraxis well in clinical studies. The most commonly reported adverse events were mild diarrhea, mild elevations in laboratory tests of liver enzymes, and headache.
