Pfizer receives FDA approval for Eraxis to treat candidemia

Feb 21 2006

Pfizer said today that Eraxis (anidulafungin) has been approved by the U.S. 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 approximately 40 percent.

In the United States, candidemia affects approximately one in 5,000 people, resulting in an estimated 60,000 cases each year. "Bloodstream infections such as candidemia can spread quickly and are very dangerous, especially for patients with weakened immune systems," said Dr. Joseph Feczko, Pfizer's chief medical officer. "Physicians treating these seriously ill patients now have an important new treatment in Eraxis."

Patients at high risk for candidemia and systemic candidiasis (Candida 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. In the U.S., patients with candidemia on average spend an additional 10 days in the hospital at an average increase in hospital charges of about $39,000 per patient.

"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, head of the Division of Infectious Diseases at Cooper University Hospital in Camden, New Jersey, 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."

Eraxis, an antifungal medicine of the echinocandin class, also was approved by the FDA to treat two additional infections caused by the Candida fungus-peritonitis and intra-abdominal abscesses -- as well as esophageal candidiasis, a fungal infection of the esophagus.

Eraxis builds upon Pfizer's extraordinary strength in medicines for the treatment of infectious diseases, particularly antifungal treatments. Pfizer's Diflucan(R) (fluconazole) has been the longstanding gold standard treatment for candidemia and other fungal infections, especially opportunistic infections in HIV/AIDS patients. Pfizer's Vfend(R) (voriconazole), also a product of innovative Pfizer research, is a treatment for serious mold and yeast infections. Both Diflucan and Vfend are azole-type antifungal treatments.

Eraxis is the only medicine that has demonstrated improved efficacy versus fluconazole in a pivotal clinical trial for the treatment of candidemia. Eraxis was added to the company's antifungal portfolio through the acquisition of Vicuron in September 2005.

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