FDA Approves Astellas’s Antifungal Drug Cresemba

March 6, 2015, 10:42 PM UTC

The Food and Drug Administration March 6 approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis.

Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis is caused by the Mucorales fungi, the agency said. These rare but serious infections occur most often in people with weakened immune systems.

Cresemba, which is marketed by Astellas Pharma US Inc., belongs to a class of drugs called azole antifungal agents, which target the cell wall of a fungus, the FDA said. Cresemba is available in oral and intravenous formulations.

“Today’s approval ...

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