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Pfizer receives US FDA approval for Eraxis to treat candidemia
New York | Wednesday, February 22, 2006, 08:00 Hrs  [IST]

Pfzier's Eraxis (anidulafungin) has been approved by the US Food and Drug Administration to treat candidemia, a potentially life-threatening bloodstream infection.

"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," added Reboli.

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 oesophageal candidiasis, a fungal infection of the oesophagus.

According to the Pfizer release, 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.

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. In the United States, candidemia affects approximately one in 5,000 people, resulting in an estimated 60,000 cases each year.

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.

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