FDA Approves Micafungin Injection for Pediatric Patients with Candidemia

The FDA has approved a supplemental New Drug Application (sNDA) for micafungin injection (Mycamine, Astellas Pharma Inc) for pediatric patients younger than 4 years of age with candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses without meningoencephalitis and/or ocular dissemination.

Micafungin injection is the first antifungal drug approved in the United States specifically for this age group of patients with invasive candidiasis. Newborns with candidiasis have a 20% mortality and significant morbidity, and infants with candidiasis have an increased mortality risk. Micafungin injection was approved for adults for Candida infections in 2005 and in 2013 for pediatric patients aged 4 months and older.

Invasive candidiasis is a fungal infection caused by a yeast known as Candida. Candidemia is a bloodstream infection with Candida and is the most common form of invasive candidiasis. Invasive candidiasis infections are often associated with high rates of morbidity and mortality, as well as increases in cost and length of hospital stay.

"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. We're pleased with this decision and the potential benefits [micafungin] may offer to young infants and their families impacted by invasive candidiasis,” said Laura Kovanda, PhD, senior director and global development project leader for Infectious Diseases and Oncology at Astellas, in a prepared statement.

The safety of micafungin was assessed in 168 pediatric patients aged 4 months and younger who received varying doses of micafungin in 9 clinical trials.

The approved dose of micafungin in neonates and young infants less than 4 months is 4 mg/kg once daily.

Reference

U.S. FDA Approves Supplemental New Drug Application (sNDA) for Expanded Indication of MYCAMINE® (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age [press release]. PR Newswire website. Published January 8, 2020. https://www.prnewswire.com/news-releases/us-fda-approves-supplemental-new-drug-application-snda-for-expanded-indication-of-mycamine-micafungin-for-injection-for-the-treatment-of-invasive-candidiasis-in-pediatric-patients-less-than-4-months-of-age-300983804.html. Accessed January 9, 2020.