The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for use of micafungin sodium (Mycamine, Astellas Pharma US) for injection by intravenous infusion in children aged 4 months or older.
The pediatric indication spans candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT), the company said.
"Candida infections are a significant concern to pediatric healthcare professionals, and there are limited treatment options," Antonio C. Arrieta, MD, director of pediatric infectious diseases, Children's Hospital of Orange County, Orange, California, and clinical professor of pediatrics, University of California, Irvine, said in a statement.
"Because Mycamine has been shown to be safe and effective in treating candidemia in many adult patients, it is an important new option for treating Candida infections in pediatric patients age four months and older," he added.
Micafungin sodium was first approved in the United States in 2005 for Candida prophylaxis and treatment in adults undergoing HSCT and for the treatment of esophageal candidiasis, as previously reported by Medscape Medical News. In 2008, indications for the drug were expanded to include candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses in adults.
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Cite this: Micafungin Sodium (Mycamine) Gets Pediatric Indication - Medscape - Jul 01, 2013.