Isavuconazole Designated Orphan Drug for Invasive Candidiasis

Astellas announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to isavuconazole for the treatment of invasive candidiasis. Isavuconazole is a once-daily intravenous and oral broad-spectrum antifungal.

In the Phase 3 invasive aspergillosis study, isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42. Also, in an open-label Phase 3 study of isavuconazole, isavuconazole demonstrated efficacy in the treatment of invasive mucormycosis (n=37).

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Previously isavuconazole was granted Orphan Drug designation for the treatment of invasive aspergillosis and invasive mucormycosis. It was also granted Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis, invasive aspergillosis, and invasive mucormycosis.

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