FDA Approves Novel Medicine to Prevent Invasive Fungal Infections

September 18, 2006 - 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.

Noxafil is manufactured by Schering Corporation, Kenilworth, NJ.

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