FDA approved Antifungal Injectable Drug for Newborns

The FDA approved the first antifungal drug to specifically treat invasive candidiasis in the youngest of infants.

The candidiasis in newborns is tied to a 20% mortality rate and is associated with significant morbidity as well.

Candidiasis is a fungal infection caused by a yeast (a type of fungus) called Candida. Some species of Candida can cause infection in people; the most common is Candida albicans. Candida normally lives on the skin and inside the body, in places such as the mouth, throat, gut, and vagina, without causing any problems. Candida can cause infections if it grows out of control or if it enters deep into the body (for example, the bloodstream or internal organs like the kidney, heart, or brain).

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.

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.