The Food and Drug Administration (FDA) has approved Cresemba (isavuconazonium sulfate; Astellas) for the treatment of invasive aspergillosis and invasive mucormycosis.

Cresemba is an azole antifungal with a Qualified Infectious Disease Product (QIDP) designation. Its priority review and subsequent approval was based on a clinical trial involving 516 patients randomized to either Cresemba or voriconazole for the treatment of invasive aspergillosis, as well as a single-arm clinical trial involving 37 patients treated with Cresemba for mucormycosis. Results from both studies showed that Cresemba was safe and effective in treating the fungal infections.

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Cresemba has been approved as both oral and intravenous (IV) formulations.

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