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Isavuconazonium: First Global Approval

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Abstract

Isavuconazonium (Cresemba®) is a water-soluble prodrug of the triazole antifungal isavuconazole (BAL 4815), a 14-α-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.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. P. L. McCormack is a salaried employee of Adis, Springer SBM.

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    Paul L. McCormack

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Correspondence to Paul L. McCormack.

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This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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McCormack, P.L. Isavuconazonium: First Global Approval. Drugs 75, 817–822 (2015). https://doi.org/10.1007/s40265-015-0398-6

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