FDA Approves New Antifungal Treatment.

Submitted by GAtherton on 17 March 2015

​FDA has approved Cresemba (isavuconazonium), a new antifungal drug to treat invasive aspergillosis and invasive mucormycosis. Cresemba was approved following an expedited review under the agency’s designation as a Qualified Infectious Disease Product. In 2010 nearly 50,000 patients were hospitalized “for treatment of aspergillosis, which most often strikes patients receiving chemotherapy, stem cell transplants, high doses of steroid medications and immune-suppressing drugs needed after organ transplants.” It’s believed the increase is due to more people living with HIV or receiving immune-suppressing drugs due to various diseases.”

MedPage Today (3/9, Gever) reports that Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement, “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.” According to the agency the most common side effects “included nausea, vomiting, diarrhea, headache, elevated liver enzymes, hypokalemia, constipation, dyspnea, peripheral edema, and cough.” Additionally, “serious liver toxicity and severe allergic and infusion reactions was also seen.”