The U.S. Food and Drug Administration approved Astellas Pharma Inc.'s Mycamine to treat certain fungal infections in children younger than 4 months of age.
The regulator approved Astellas' supplemental new drug application to treat candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis and\or ocular dissemination.
Invasive candidiasis is a fungal infection caused by a yeast called candida. Candidemia is a bloodstream infection with candida and is the most common form of invasive candidiasis.
According to an estimate by the Centers for Disease Control, about 25,000 new cases of candidemia occur in the U.S. each year.
Mycamine, or micafungin, is an injection that is already approved to treat candida fungus infections in adults and children who are at least 4 months old.
The FDA's approval is based on data from nine clinical studies that assessed the safety of different doses of the medication in 168 pediatric patients younger than 4 months of age.