FDA approves Pfizer's Eraxis for candidemia bloodstream infection

By Lisa Kerner

Erie, Pa., Feb. 21 - Pfizer Inc said that Eraxis (anidulafungin) has been approved by the Food and Drug Administration to treat candidemia, a potentially life-threatening bloodstream infection.

Candidemia is the most deadly of the common hospital-acquired bloodstream infections, with a mortality rate of about 40%, according to a company news release. There are roughly 60,000 cases each year in the United States.

Patients at high risk for candidemia and systemic candidiasis (infection that spreads throughout the body) include those with compromised immune systems, stem-cell and organ-transplant recipients, patients on chemotherapy, patients with catheters, critically ill patients in intensive care units, surgical patients and patients on prolonged antibiotic therapy.

The FDA also approved Eraxis, an antifungal medicine, for the treatment peritonitis and intra-abdominal abscesses Candida fungus, as well as esophageal candidiasis, a fungal infection of the esophagus.

Eraxis is the only medicine that has demonstrated improved efficacy versus fluconazole in a pivotal clinical trial for the treatment of candidemia, the company said.

"In the clinical trial setting, patients taking Eraxis for the treatment of candidemia had improved efficacy versus those taking fluconazole, making Eraxis an important addition to the options in antifungal treatment," said Dr. Annette Reboli of Cooper University Hospital in Camden, N.J., and lead clinical investigator.

"In addition, Eraxis has been shown to have a safety profile comparable to fluconazole and to be compatible with many medicines commonly used by patients with candidemia who have other serious health complications."

New York-based Pfizer discovers, develops, manufactures and markets prescription medicines and consumer brands.

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