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www.fdanews.com/articles/86089-astellas-submits-application-to-market-antifungal-treatment-in-eu

ASTELLAS SUBMITS APPLICATION TO MARKET ANTIFUNGAL TREATMENT IN EU

April 17, 2006

Japanese drugmaker Astellas has reported that its EU subsidiary has submitted a marketing authorization application for the candin antifungal agent micafungin for the treatment of systemic fungal infections to the European Medicines Agency (EMEA).

Micafungin 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. The drug, launched as Funguard in Japan in December 2002 and as Mycamine in the U.S. in May 2005, has shown promise in the treatment and prophylaxis of systemic fungal infections.