NEW ANTIFUNGAL DRUG APPROVED IN THE U.S.

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

Noxafil, a new molecular entity, is an antifungal drug that contains an active substance that has never before been approved for marketing in any form in the United States. The drug is manufactured by Schering.

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, the patients who received Noxafil had comparable or lower rates of invasive Aspergillus and Candida infections than the patients who received other antifungal medications.