FDA approves sNDA for candidiasis treatment in paediatric patients
Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Astellas Pharma Inc’s MYCAMINE® (micafungin for injection) for the treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in paediatric patients younger under four months.
This approval means that MYCAMINE is the first antifungal drug approved in the US specifically for the treatment of invasive candidiasis for this patient population. MYCAMINE was approved for adults for Candida infections in 2005 and in 2013 for paediatric patients aged four months and older.
We’re pleased with this decision and the potential benefits MYCAMINE may offer to young infants”
“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 Dr Laura Kovanda, Senior Director, Global Development Project Leader, Infectious Diseases and Oncology, Astellas. “We’re pleased with this decision and the potential benefits MYCAMINE may offer to young infants and their families impacted by invasive candidiasis.”
The safety of MYCAMINE was assessed in 168 paediatric patients younger than four months of age who received varying doses of MYCAMINE in nine clinical trials, the company said. The approved dose for the treatment in neonates and young infants less than four months is 4mg/kg once daily.