FDA Approves New Treatment for Fungal Infections

[Guest guest]

FDA News

FOR IMMEDIATE RELEASE

P06-27

February 21, 2006

Media Inquiries:

Rae , 301-827-6242

Consumer Inquiries:

888-INFO-FDA

http://www.fda.gov/bbs/topics/news/2006/NEW01321.html

FDA Approves New Treatment for Fungal Infections

The Food and Drug Administration approved Eraxis™ (anidulafungin) to

treat certain infections caused by Candida, a yeast-like fungus that

can cause serious infections in hospitalized patients or patients

with compromised immune systems.

" This product offers a new alternative therapy for several types of

infections associated with Candida " , said Dr. Galson,

director of the FDA's Center for Drug Evaluation and Research. " It

is a helpful addition to the available antifungal medications that

can be used in the treatment of these potentially serious fungal

conditions. "

Eraxis, a new molecular entity that has never been marketed in the

United States, is an antifungal drug that is administered

intravenously, and is used to treat Candida infections in the

esophagus (candidiasis), blood stream (candidemia), and other forms

of Candida infections, including abdominal abscesses and peritonitis

(inflammation of the lining of the abdominal cavity).

The safety and efficacy of Eraxis was evaluated in clinical studies

and Eraxis was shown to be safe and effective in the treatment of

esophageal candidiasis, candidemia, and other Candida infections

including abdominal abscesses and peritonitis.

Eraxis was generally well tolerated in clinical studies. The most

commonly reported adverse events were mild diarrhea, mild elevations

in laboratory tests of liver enzymes, and headache. Some patients

experienced infusion-related reactions, most of which were mild. In

a few patients with significant underlying medical conditions who

were on multiple concomitant medications, there were reports of

serious hepatic abnormalities.

Eraxis is manufactured by Pfizer Inc., New York, NY.

####