The U.S. Food and Drug Administration said Monday it approved a new type of drug by Schering-Plough Corp. (SGP) to prevent invasive fungal infections in patients with weakened immune systems.
The drug, Noxafil, is designed to prevent fungal infections caused by certain molds and yeast-like fungus called Aspergillus and Candida. More recent approvals at Drug Pipeline Database
The agency specifically approved the drug for use in patients with weakened immune systems following bone-marrow transplants and for patients with decreased white blood cell count following chemotherapy treatment 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."
The FDA said Noxafil includes an active substance that has never before been approved for marketing in any form in the United States.
The drug was studied in 1,844 patients between 13 and 82 years of age in two studies. Those patients had compromised immunity and were at high risk for invasive fungal infections. 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. The agency said rare side effects possibly related to the drug include abnormal heart rhythm and liver-function impairment.
The agency said 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. The FDA also said doctors prescribing the drug need to be aware that Noxafil can interact with several other medications.
No comments:
Post a Comment