FDA Approves Novel Medicine to Prevent Invasive Fungal Infections


FDA News

September 18, 2006

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Laura Alvey, 301-827-6242
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FDA Approves Novel Medicine to Prevent Invasive Fungal Infections

The U.S. Food and Drug Administration today approved Noxafil
(posaconazole) to prevent fungal infections caused by certain molds and
yeast-like fungus called Aspergillus and Candida. FDA approved the drug
for use in patients who have weakened immune systems following bone
marrow transplants and for patients with a condition (decreased white
blood cell counts) that makes it difficult for the body to fight
infections following chemotherapy for cancer.

“Most healthy individuals are unaffected by these common fungi,” said
Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and
Research. “However, individuals with severely weakened or abnormal
immune systems may become seriously ill when exposed. These infections
are often fatal for this population.”

Noxafil, a new molecular entity (NME), is an antifungal drug which
contains an active substance that has never before been approved for
marketing in any form in the United States.

The safety and efficacy of Noxafil were evaluated in clinical trials
consisting of 1,844 patients between 13 and 82 years of age. In two,
randomized, controlled studies of patients who had compromised immunity
and were at high risk for invasive fungal infections, those patients
who received Noxafil had comparable or lower rates of invasive
Aspergillus and Candida infections than those patients who received
other antifungal medications.

The most common side effects in patients receiving Noxafil were nausea,
vomiting, diarrhea, rash, a decrease in potassium blood levels and
platelet counts, and abnormalities in liver function tests. Rare
adverse events possibly related to the drug include QTc prolongation
(abnormal heart rhythm) and liver function impairment.

Noxafil must be taken with a full meal or nutritional supplement (a
product intended as a supplement to the diet) to allow adequate
absorption of the drug into the body so it can take effect. Noxafil has
been shown to interact with several medications, including drugs that
suppress the immune system, and these reactions may be serious. The
product label should be consulted when other drugs are prescribed with

Noxafil is manufactured by Schering Corporation, Kenilworth, NJ.