FDA approves IV antifungal drug for infants

The FDA has approved a supplemental new drug application for the use of micafungin sodium for certain Candida infections in patients as young as 4 months, according to a press release.

Micafungin sodium (Mycamine, Astellas) is now indicated for injection by IV infusion for the treatment of patients aged 4 months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants.

The overall safety of micafungin sodium was assessed in 479 patients, aged 3 days to 16 years, who received at least one dose of micafungin sodium in 11 separate clinical trials. The mean treatment duration was 24.8 days. In all pediatric studies with micafungin sodium, 439 of 479 (92%) patients experienced at least one treatment-emergent adverse reaction.

The most common (at least 15%) treatment-emergent adverse reactions observed in all children aged 4 months and older treated with micafungin sodium included: vomiting (31%), diarrhea (22%), pyrexia (22%), nausea (19%), abdominal pain (16%) and thrombocytopenia (15%).

Click here to read the FDA approval letter.