FDA Approves New Antifungal Drug

The FDA recently approved the new antifungal drug, Cresemba (isavuconzonium sulfate), to treat adults with the rare conditions invasive mucormycosis and invasive aspergillosis.

“Today’s approval provides a new treatment option for patients with serious fungal infections and underscores the importance of having available safe and effective antifungal drugs,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
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Cresemba was the sixth antibacterial or antifungal drug product to be approved and designated as a Qualified Infectious Disease Product (QIDP).

To determine the safety and efficacy of Cresemba to treat invasive aspergillosis, a clinical trial of 516 participants was conducted. Participants were randomly assigned Cresemba or voriconzole, another drug approved to treat the illness.

Further, the efficacy and safety of invasive mucormycosis treatment was based on a single-arm clinical trial, which involved 37 participants treated with Cresemba. The participants were then compared to the inherent disease progression of untreated mucormycosis.

According to the FDA, the most common side effects linked to Cresemba use included headache, abnormal liver blood tests, low potassium levels in the blood, dyspnea, constipation, diarrhea, vomiting, nausea, coughing and tissue swelling.

Some serious side effects could include severe allergic and skin reactions, infusion reactions, and liver problems.

The complete news release is published on the FDA’s website.

-Michelle Canales Butcher

Reference:

US Food and Drug Administration. FDA approves new antifungal drug Cresemba. March 6, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437106.htm. Accessed March 9, 2015.