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FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Candidiasis
Date:7/16/2014

nazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42.  The treatment-emergent adverse events for isavuconazole were statistically fewer relative to voriconazole in the System Organ Classes of hepatobiliary, skin and eye disorders. In both treatment groups, the most common treatment emergent adverse events were nausea, vomiting, pyrexia (fever) and diarrhea.

Isavuconazole is being co-developed with Basilea Pharmaceutica International Ltd.

About Astellas Infectious Disease
Astellas' commitment to the field of infectious diseases is an active one. We're expanding the knowledge base of this therapeutic area and empowering physicians to make evidence-based clinical decisions.

Our proud history of collaborating with investigators around the world provides ideal environments to study compounds that have the potential for significant breakthroughs and allows us to generate and publish key information on our advances. In fact, Astellas has performed some of the world's largest clinical trials in fungal infections.

About Astellas
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. The headquarters for the Americas is located in Northbrook, Ill. For more information on Astellas, please visit our website at www.astellas.us.

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