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FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Aspergillosis
Date:12/3/2013

aspergillosis is caused by Aspergillus molds and typically affects patients with an impaired or weakened immune system. It is estimated to occur in five to 13 percent of recipients of bone marrow transplants often associated with leukemia, five to 25 percent of patients who have received heart or lung transplants, and 10 to 20 percent of patients who are receiving intensive chemotherapy for leukemia.[3] Mortality rates for transplant patients with invasive aspergillosis have been reported to be between 34 and 58 percent.[4] Zygomycosis is an important emerging fungal infection, associated with high morbidity and mortality. Mortality rates have been reported to be as high as 80 percent in infected transplant patients.[5]

About isavuconazole
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once daily intravenous and oral broad-spectrum antifungal for the potential treatment of severe invasive and life-threatening fungal infections. It is currently in phase 3 of clinical development. Isavuconazole demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as activity in in-vitro studies and animal models against emerging and often fatal molds including those that cause zygomycosis. Isavuconazole received U.S. FDA fast-track status and U.S. orphan drug designation for invasive aspergillosis and zygomycosis. Isavuconazole is being co-developed with Basilea Pharmaceutica Ltd.

About the isavuconazole phase 3 program
The phase 3 program with isavuconazole includes three studies, SECURE, VITAL and ACTIVE. Recently, positive topline results were reported from the SECURE study, a global randomized, double-blind phase 3 study, designed to evaluate the safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole in the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi
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SOURCE Astellas Pharma US, Inc.
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