The newly approved agent will be marketed in the US under the name Mycamine (micafungin sodium for injection).
The approval is based on 32 clinical studies conducted in the US, Canada, Japan, South America, Europe and Africa and including data from 2402 subjects.
Subjects in the Mycamine studies included a broad range of individuals who had a confirmed, or were at risk for, candida fungal infections, including patients with hematologic malignancies, bone marrow transplant recipients, and HIV-positive patients. In three large, well controlled, clinical trials, Mycamine has been shown to have an overall safety profile, and discontinuation rate, similar to that of fluconazole.
“This is an important milestone in Fujisawa’s commitment to develop novel compounds that help patients with serious diseases,” said Hideo Fukumoto, chairman and CEO of Fujisawa. “Mycamine will allow us to expand our depth in the anti-fungal market and offer patients another treatment option to fight or prevent a life-threatening candida infection.”
Currently, Fujisawa markets the anti-fungal AmBisome (a liposomal formulation of amphotericin B) in the US.