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On March 6, 2015, the FDA announced approval of isavuconazonium (Cresemba) for treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in adults. For IA, it was found noninferior to voriconazole for all-cause mortality in a randomized trial involving 516 patients. Overall end-of-treatment response rates were also similar between groups. For IM, approval was based on an open-label, single-arm study with 37 patients. All-cause mortality was 38% at day 42, and the overall end-of-treatment success rate was 31%.
A prodrug of isavuconazole, isavuconazonium is available in intravenous and oral formulations, which are bioequivalent. It is given every 8 hours for the first six doses, then daily, and does not require dosage adjustment …