The FDA approved the first antifungal drug to specifically treat invasive candidiasis in the youngest of infants, manufacturer Astellas announced on Wednesday.
A supplemental new drug application for injection micafungin (Mycamine) was approved to treat the bloodstream infection, candidemia, acute disseminated candidiasis (where the infection progresses to other organs), Candida peritonitis (inflammation of the membrane lining the abdominal wall), and abscesses without meningoencephalitis and/or ocular dissemination in infants younger than 4 months of age, the manufacturer said in a statement.
This is an expanded indication for the micafungin injection, which was first approved to treat adults with esophageal candidiasis back in 2005, and in 2008 for adults with candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses. A pediatric indication for the drug was approved in 2013, but for children 4 months and older.
The manufacturer noted that candidiasis in newborns is tied to a 20% mortality rate and is associated with significant morbidity as well.
“Although rare, invasive candidiasis in newborns constitutes a unique pathogenesis unlike that demonstrated in older children and adults as marked by a higher incidence of organ involvement, especially in the central nervous system,” Astellas senior director Laura Kovanda, PhD, said in a statement.
The drug’s safety in this population was assessed in 168 pediatric patients in nine clinical trials testing various doses, the manufacturer said. They noted that the safety and effectiveness of the micafungin injection has not been established for candidemia with meningoencephalitis and/or ocular dissemination among infants younger than 4 months, as these may require a higher dose.
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