Astellas Pharma US, Inc., a US subsidiary of Tokyo-based Astellas Pharma Inc. has received the US Food and Drug Administration (FDA) approval for its Supplemental New Drug Application (sNDA) for the use of Mycamine (micafungin sodium) for injection by intravenous infusion for the treatment of paediatric 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 paediatric patients four months and older," said Sef Kurstjens, MD, 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 paediatric healthcare professionals, and there are limited treatment options," said Antonio C Arrieta, MD, director Paediatric Infectious Diseases, Children's Hospital of Orange County and Clinical Professor, Paediatrics, 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 paediatric 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 paediatric patients and additional paediatric pharmacokinetic and safety data. Two randomized, double-blind, active controlled studies investigated the safety and efficacy of Mycamine in both adult and paediatric 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 paediatric 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 paediatric patients age four months and older were: vomiting (31%), diarrhoea (22%), pyrexia [fever (22%)], nausea (19%), abdominal pain (16%) and thrombocytopenia [low blood platelet levels (15%)].
Candida is a type of yeast that causes common fungal infections. Candida normally lives on the skin without illness, however, overgrowth and compromised immune systems can lead to symptoms of infection. Candidemia occurs when Candida enters the bloodstream, which can lead to spread of the infection to other parts of the body.
Candida species are the third most common cause of paediatric health care associated bloodstream infection.
Mycamine is a member of a class of anti-fungal agents, the echinocandins. Mycamine inhibits an enzyme essential for fungal cell-wall synthesis and is fungicidal (lethal) for Candida.
Astellas Pharma US, Inc., is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.