Pfizer Receives FDA Approval For EraxisTM To Treat Candidemia, A Potentially Life-Threatening Bloodstream Infection

Main Category: MRSA / Drug Resistance
Article Date: 27 Feb 2006 - 3:00 PDT

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Pfizer Inc said today that EraxisTM (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® (fluconazole) has been the longstanding gold standard treatment for candidemia and other fungal infections, especially opportunistic infections in HIV/AIDS patients. Pfizer's Vfend® (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.

About Candida Infections

Candidemia is a systemic fungal infection that occurs when Candida organisms are present in the blood. The bloodstream may then spread Candida to organs and tissues throughout the body, causing systemic candidiasis.

Systemic candidiasis is difficult to diagnose and can cause organ failure, which may result in death. It can infect organs such as the kidneys, liver, bones, muscles, joints, spleen, or eyes.

Esophageal candidiasis is a fungal infection of the esophagus that is most common among people with compromised immune systems such as people with HIV/AIDS.

About Eraxis

Eraxis is an antifungal agent indicated for the treatment of candidemia and two other Candida infections, peritonitis (infection of the abdominal cavity) and intra-abdominal abscesses. Eraxis has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida, and has not been studied in sufficient numbers of neutropenic patients (those with low white blood cell counts) to determine efficacy in this group. It was also approved for esophageal candidiasis, an infection of the esophagus caused by Candida (relapse rates post-therapy were higher for patients on Eraxis).

Important Safety Information

In clinical studies, Eraxis was as well tolerated as fluconazole and the total number of drug-related adverse events was comparable to fluconazole. The most common treatment-related adverse events for Eraxis in the candidemia study included lower than normal levels of potassium in the blood (3.1%), diarrhea (3.1%), and an increase in ALT (a liver enzyme) (2.3%). In the esophageal candidiasis study, the most common treatment-related adverse events for Eraxis were headache (1.3%) and an increase of GGT (a liver enzyme) (1.3%).

Eraxis has not been associated with renal toxicity, and has no clinically relevant drug-to-drug interactions. Eraxis also does not require dose adjustments based on gender, race, age, HIV status, hepatic insufficiency or renal insufficiency. (Safety and effectiveness of Eraxis in pediatric patients has not been established.)

Eraxis is not approved for use in patients with hypersensitivity to anidulafungin, any component of Eraxis, or other echinocandin agents. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with Eraxis, clinically significant hepatic abnormalities have occurred. Possible histamine-mediated symptoms have been reported infrequently with Eraxis, including rash, urticaria, flushing, pruritis, dyspnea, and hypotension.

Health care providers can get more information about Eraxis by calling 1-800-438-1985. Information about Eraxis can also be found at http://www.eraxisrx.com.

http://www.pfizer.com