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.