Astellas announced that the FDA has approved its Supplemental New Drug Application (sNDA) for Mycamine (micafungin sodium) for injection by intravenous infusion for the treatment of pediatric patients >4 months with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT).
The overall safety of Mycamine in pediatric patients >4 months was evaluated in 11 separate clinical trials. A total of 479 patients ages 3 days–16years received at least one dose of Mycamine for a mean duration of 24.8 days. Two randomized, double-blind, active-controlled studies also investigated the safety and efficacy of Mycamine in both adult and pediatric patients.
Mycamine, an echinocandin, was first approved in 2005 for the treatment of esophageal candidiasis and for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. Then in 2008, the FDA approved Mycamine for the treatment of candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses.
For more information call (800) 727-7003 or visit Mycamine.com.