Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) has today announced that the candin antifungal agent, "Funguard® for Infusion" (generic name: micafungin sodium), was approved for pediatrics in Japan on April 20, 2006.

Micafungin, discovered and generated by Astellas, is a member of a new class of antifungal agents for injection, the candins. The novel mechanism of action of micafungin specifically interferes with fungal cell wall biosynthesis by selective inhibition of (1,3)-beta-D-glucan synthase. (1,3)-beta-D-glucan is an essential component of the skeletal structure of the fungal cell wall which is absent in mammalian cells. In Japan, micafungin has been marketed as "Funguard® for Infusion" for adults since December 2002 and approved as a first systemic antifungal agent for pediatrics in Japan. "Funguard® for Infusion" is now available for pediatrics in Japan.

Astellas positions micafungin as one of its important products. Astellas has marketed it as "Mycamine®" in the US since May 2005 and has submitted a Marketing Authorization Application (MAA) for the treatment of systemic fungal infections to the European Medicines Agency (EMEA) in April 2006. With an approval for pediatrics in Japan, "Funguard® for Infusion" will further contribute to the treatment of systemic fungal infections. Funguard® for Infusion 25mg was also approved on the same day.

Additional information for Funguard® for Infusion for pediatrics is mentioned as follows;

APPROVAL DATE April 20, 2006
PRODUCT NAME Funguard® for Infusion 50mg, Funguard® for Infusion 75mg 
GENERIC NAME micafungin sodium
REIMBURSEMENT PRICE 7,007 yen for 50mg, 10,097 yen for 75mg 
INDICACIONS Infections caused by Aspergillus sp. and Candida sp. such as fungemia, respiratory mycosis and gastrointestinal mycosis


DOSAGE AND ADMINISTRATION:

Aspergillosis: For pediatrics, the usual single daily dose is 1 - 3 mg (potency) /kg of micafungin sodium and this product should be infused intravenously once daily. The dosage can be increased according to the patient's condition for severe or refractory aspergillosis up to 6 mg (potency)/kg/day.

Candidiasis: For pediatrics, the usual single daily dose is 1 mg (potency)/kg of micafungin sodium and this product should be infused intravenously once daily. The dosage can be increased according to the patient's condition for severe or refractory candidiasis up to 6 mg (potency)/kg/day.