The Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection; Astellas Pharma) for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients aged <4 months. Previously, Mycamine was indicated only for patients aged ≥4 months for Candida infections.
The approval was based on data from clinical trials that evaluated the safety of Mycamine in 168 patients aged <4 months at varying doses. The safety and efficacy of Mycamine in this patient population have not been established for the treatment of esophageal candidiasis and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT).
Regarding safety, the most common adverse reactions in pediatric patients younger than 4 months old receiving Mycamine included hypokalemia, thrombocytopenia, acidosis, sepsis, anemia, decreased oxygen saturation, and vomiting.
“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. “We’re pleased with this decision and the potential benefits Mycamine may offer to young infants and their families impacted by invasive candidiasis.”
The product is supplied as 50mg and 100mg strength single-dose vials for IV infusion after reconstitution.
For more information visit astellas.com.