U.S. FDA approves supplemental new drug application for expanded indication of Mycamine (micafungin for injection) for the treatment of invasive candidiasis in paediatric patients less than 4 months of age

Astellas

8 January 2020 - Astellas Pharma today announced that the U.S. FDA has approved its supplemental new drug application for Mycamine (micafungin for injection) in support of the treatment of candidaemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in paediatric patients younger than 4 months of age.

With the approval, Mycamine is the first anti-fungal 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 paediatric patients aged four months and older.

The safety of Mycamine was assessed in 168 paediatric patients younger than 4 months of age who received varying doses of Mycamine in nine clinical trials.

Read Astellas press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics