The FDA has approved a supplemental new drug application for micafungin for the treatment of invasive candidiasis in pediatric patients under 4 months of age.
The US Food and Drug Administration has approved a supplemental new drug application for micafungin for injection (Mycamine).
The approval grants authorization for the product to be used to treat candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses without meningoencephalitis and/or ocular dissemination in pediatric populations under 4 months of age. The approval was granted to Astella Pharma Inc.
The product is an echinocandin which has previously been approved for use in adult and pediatric patients. It inhibits and enzyme essential for fungal cell wall synthesis and is fungicidal for Candida.
The safety of the product was clinically evaluated in 168 pediatric patients under 4 months of age. In the research, the patients received varying doses of the injection across 9 clinical trials. The approved dose in this population is 4 mg/kg once daily.
The most common adverse reactions across all pediatric and adult clinical trials included diarrhea, nausea, vomiting, pyrexia, thrombocytopenia, neutropenia, headache and abdominal pain. In pediatric patients, other common adverse reactions that were reported at an incidence rate of >15% included sepsis, acidosis, anemia, a decrease of oxygen, and hypokalemia.
Micafungin for injection can also be used concomitantly with several other drugs including ritonavir and cyclosporine and tacrolimus.
"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," said Laura Kovanda, PhD, senior director, global development project leader, infectious diseases and oncology, Astellas in the statement. "We're pleased with this decision and the potential benefits MYCAMINE may offer to young infants and their families impacted by invasive candidiasis."