The FDA has accepted Astellas’ supplementary application to authorize Cresemba for the treatment of invasive fungal infections in pediatric patients aged 1 to 17 years. Cresemba, which includes isavuconazonium sulfate as an active component, is now licensed for the treatment of invasive aspergillosis and mucormycosis in adults. The pediatric application is based on clinical trial results from 31 children who received isavuconazonium sulfate intravenously or orally. The trial demonstrated the drug’s potential effectiveness and safety in pediatric patients. Cresemba, if authorized, would provide a therapy alternative for these sometimes fatal fungal infections in younger individuals. Astellas expects that Cresemba will be provided to critically ill pediatric patients and their doctors. A decision date of December 9, 2023, has been set.

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