FDA Approves Pediatric Indication for Astellas' MYCAMINE® (micafungin sodium) for Injection

NORTHBROOK, Ill., June 24, 2013 /PRNewswire/ --Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:4503), announced that the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) for the use of MYCAMINE (micafungin sodium) for injection by intravenous infusion for the treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT).

"We are pleased with FDA's approval of MYCAMINE for use in pediatric patients four months and older," said Sef Kurstjens, M.D., chief medical officer, Astellas Pharma, Inc. "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."

"Candida infections are a significant concern to pediatric healthcare professionals, and there are limited treatment options," said Antonio C. Arrieta, M.D., Director Pediatric Infectious Diseases, Children's Hospital of Orange County and Clinical Professor, Pediatrics, University of California, Irvine. "Because MYCAMINE has been shown to be safe and effective in treating candidemia in many adult patients, it is an important new option for treating Candida infections in pediatric patients age four months and older."

Safety and effectiveness of MYCAMINE in pediatric patients four months and older have been demonstrated based on the evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. Two randomized, double-blind, active controlled studies investigated the safety and efficacy of MYCAMINE in both adult and pediatric patients: one for the treatment of invasive candidiasis and candidemia, and the other for prophylaxis of Candida infections in patients undergoing HSCT. Safety and effectiveness of MYCAMINE in patients younger than four months of age have not been established.

The overall safety of MYCAMINE was assessed in 479 patients, ages three days through 16 years, who received at least one dose of MYCAMINE in 11 separate clinical trials. The mean treatment duration was 24.8 days. In all pediatric studies with MYCAMINE, 439 of 479 (92%) patients experienced at least one treatment-emergent adverse reaction. The most common (15%) TEAEs observed in all MYCAMINE-treated pediatric patients age four months and older were: vomiting (31%), diarrhea (22%), pyrexia [fever (22%)], nausea (19%), abdominal pain (16%) and thrombocytopenia [low blood platelet levels (15%)].

MYCAMINE dosage in pediatric patients age four months and older is as follows:

Indication

Pediatric Dose Given Once Daily

30 kg or less

Greater than 30 kg

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FDA Approves Pediatric Indication for Astellas' MYCAMINE® (micafungin sodium) for Injection