FDA Approves New Antifungal Drug Cresemba

The FDA today approved isavuconazonium sulfate (Cresemba) for adults with invasive aspergillosis and invasive mucormycosis.

This new antifungal drug, available in both oral and intravenous formulations, will be an option for patients with these rare but serious infections that often occur in individuals with weakened immune systems.

Cresemba’s approval for treating invasive aspergillosis was based on a clinical trial of 516 patients who received either Cresemba or voriconazole, another drug approved for the infection. Cresemba was also studied for its efficacy in treating mucormycosis in a single-arm clinical trial of 37 patients treated with Cresemba and compared with the natural disease progression associated with untreated mucormycosis. Both studies demonstrated that Cresemba was a safe and effective treatment option for these infections, according to the FDA.

“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,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

Adverse side effects of Cresemba may include nausea, vomiting, diarrhea, headache, abnormal liver blood tests, serious allergic and skin reactions, and constipation.