The FDA has approved the use of Astellas Pharma US' Mycamine (micafungin sodium) for injection to treat pediatric patients aged four months and more with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis.
The Supplemental New Drug Application (sNDA) of Mycamine is also indicated for patients with prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT).
Astellas Pharma chief medical officer Sef Kurstjens said, "This expanded indication supports the safety and efficacy of MYCAMINE and delivers on our mission to provide treatments that can help to improve patient care."
Two randomized, double-blind, active controlled studies established the safety and efficacy of Mycamine in pediatric and adult patients.
In 11 separate clinical trials, the overall safety of Mycamine was assessed in 479 patients between three days to 16 years of age with the mean treatment duration of 24.8 days.
The most common treatment-emergent adverse reactions observed in all Mycamine-treated pediatric patients were vomiting, diarrhea, pyrexia, nausea, abdominal pain and thrombocytopenia.
