FDA Approves Antifungal for Immunosuppressed Patients

ROCKVILLE, Md., Sept. 21 -- The FDA has approved Noxafil (posaconazole) to prevent invasive Aspergillus and Candida infections in immunosuppressed patients.

The agency said Noxafil, a triazole antifungal with an active substance that has never before been approved for marketing in any form in the U.S., could be used for patients who have undergone bone marrow transplants or are having chemotherapy. It is a cherry-flavored immediate-release suspension agent.

Steven Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research noted that these fungal infections, not a serious problem for healthy patients, may be fatal for those with weakened or abnormal immune systems.

The safety and efficacy of Noxafil, made by Schering, were evaluated in clinical trials with 1,844 patients 13 to 82 years old. 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 treated with 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 and impaired liver function.

Noxafil must be taken with a full meal or nutritional supplement to allow adequate absorption of the drug into the body so it can take effect, said the FDA.

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, said the agency.