The US FDA has approved the use of micafungin sodium, the antifungal product for prophylaxis of Candida infections in patients undergoing haematopoietic stem cell transplantation and the treatment of esophageal candidiasis. The newly approved agent will be marketed in the United States under the name Mycamine (micafungin sodium for injection) by Fujisawa Healthcare, Inc, the company announced here.

Mycamine is a member of a new class of antifungal agents, the echinocandins, which inhibit cell-wall synthesis. The novel mechanism of action of echinocandins specifically targets the wall of fungal cells to treat the infection.

Hideo Fukumoto, chairman and CEO, Fujisawa Healthcare, Inc said, "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 United States.
According to a recent study, invasive candidiasis kills 10 - 40 per cent of infected immunocompromised patients.

"Immuno-compromised patients whose white blood cell contents are lowered are highly susceptible to candida infections," Ira D. Lawrence, senior vice president, Research and Development said adding, "Mycamine can be an effective preventative therapy for immunocompromised patients who undergo bone marrow or stem cell transplants and are highly susceptible to candida fungal infections."

The approval is based on 32 clinical studies conducted in the United States, Canada, Japan, South America, Europe and Africa. In 3 large, well-controlled, clinical trials, Mycamine has been shown to have an overall safety profile, and discontinuation rate, similar to that of fluconazole, the company release said here.

Fujisawa Healthcare, Inc. is a subsidiary of Fujisawa Pharmaceutical Co., Ltd. based in Osaka, Japan.