Mycamine Approved for New Indication

December 24, 2019 – The U.S. FDA has approved a new indication for Mycamine® (micafungin for injection), manufactured by Astellas Pharmaceuticals. The product is now indicated to treat candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in patients who are less than four months of age. Mycamine is the first antifungal to receive FDA approval for the treatment of invasive candidiasis in this patient population.

A type of fungal infection caused by Candida yeast species, invasive candidiasis can be extremely dangerous in infants. The disease can affect multiple organs, such as the heart, lungs, eyes, and brain, as well as the blood and bones. Newborns are at greater risk of organ involvement, particularly the central nervous system, than adults or older children.

Approval for Mycamine’s new indication was supported in part by nine clinical trials that established the drug’s safety in patients who are less than four months old. Recommended dosing for this age group is 4mg/kg of body weight, with the Mycamine administered via intravenous (IV) infusion over the course of one hour. The length of treatment varies. The mean duration of treatment is 15 days for patients successfully treated for candidemia and other Candida infections, though treatment lengths of 10 to 47 days have been recorded.

First FDA approved in 2005, Mycamine is also indicated to treat candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses (with or without meningoencephalitis and/or ocular dissemination), and esophageal candidiasis in patients who are at least four months of age. It is also indicated to provide prophylaxis of Candida Infections in patients who are at least four months old and undergoing hematopoietic stem cell transplantation (HSCT).