Isavuconazonium: First Global Approval

Isavuconazonium (Cresemba (R)) is a water-soluble prodrug of the triazole antifungal isavuconazole (BAL 4815), a 14-alpha-demethylase inhibitor, under development by Basilea Pharmaceutica International Ltd and Astellas Pharma Inc. Isavuconazonium, in both its intravenous and oral formulations, was approved for the treatment of invasive aspergillosis and invasive mucormycosis (formerly termed zygomycosis) in the US in March 2015. Isavuconazonium is under regulatory review in the EU for invasive aspergillosis and mucormycosis. It is also under phase III development worldwide for the treatment of invasive candidiasis and candidaemia. This article summarizes the milestones in the development of isavuconazonium leading to the first approval for invasive aspergillosis and mucormycosis.