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Medicines licensing

FDA grants priority approval for new antifungal

Isavuconazonium sulfate (Cresemba), an antifungal developed by Astellas, has been given priority approval by the US Food and Drug Administration (FDA) to treat patients with the rare but serious infections invasive aspergillosis and invasive mucormycosis.

The drug is the sixth to be awarded qualified infectious disease product (QIDP) status, which means it was given priority review by the medicines regulator because of its potential to treat serious infections.

It has also been recognised as an orphan drug by the FDA for the two conditions and, because of its QIDP status, was given an additional five years of marketing exclusivity.

The decision to approve the drug for invasive aspergillosis was based on clinical trial results for 516 patients that compared isavuconazonium with voriconazole. All-cause mortality at six weeks was 18.6% in the isavuconazonium group and 20.2% in the voriconazole group, according to Astellas.

The drug’s approval for invasive mucormycosis was based on data from a trial of 37 patients that compared isavuconazonium treatment against the natural progression of the disease, in patients who were left untreated. All-cause mortality for isavuconazonium patients was 38%, according to Astellas.

A spokesperson for the company says it will launch Cresemba in the United States “in the coming months”.

Basilea Medical has the rights to market the product in the European Union and submitted an application for marketing authorisation to the European Medicines Agency in July 2014. The company expects the drug to be made available for the treatment of invasive aspergillosis and mucormycosis by the end of 2015.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068109

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