FDA approves sNDA for Mycamine in candidemia, acute disseminated candidiasis, candida peritonitis and abscesses for pediatric patients.- Astellas

Astellas Pharma Inc. announced that the FDA has approved its supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection) in support of the treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age. With the approval, Mycamine is the first antifungal drug approved in the United States specifically for the treatment of invasive candidiasis for this patient population. Candidiasis in newborns is associated with 20 percent mortality and significant morbidity and mortality in infants. Mycamine was approved for adults for Candida infections in 2005, and in 2013 for pediatric patients aged four months and older. The safety of Mycamine was assessed in 168 pediatric patients younger than 4 months of age who received varying doses of Mycamine in nine clinical trials. The approved dose for Mycamine in neonates and young infants less than four months is 4 mg/kg once daily.