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Cresemba Approved for Serious Fungal Infections

FRIDAY, March 6, 2015 -- Cresemba (isavuconazonium sulfate) has been approved by the U.S. Food and Drug Administration to treat rare but serious fungal infections, mostly affecting people with weakened immune systems, the agency said Friday in a news release.

The infections are caused by Aspergillus and Mucorales fungi. The new drug, targeting the cell walls of the fungi, is available in oral and intravenous formulations.

Cresmba's safety and effectiveness were evaluated in clinical studies involving more than 500 people. The most common side effects included nausea, vomiting, diarrhea, headache, low blood potassium, constipation, shortness of breath, coughing and tissue swelling. More serious adverse effects could include liver problems and allergic reactions.

Cresemba is marketed by Astellas Pharma US, based in Northbrook, Ill.

More information

The FDA has more about this approval.

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Posted: March 2015


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