FDA Approves Fidaxomicin for C difficile Treatment

Emma Hitt, PhD

The US Food and Drug Administration (FDA) on Friday approved the macrolide antibacterial fidaxomicin (Dificid, Optimer Pharmaceuticals Inc) for the treatment of Clostridium difficile–associated diarrhea (CDAD).
Approval of fidaxomicin tablets was based on 2 trials involving 564 patients with CDAD. In those trials, fidaxomicin was shown to have efficacy and safety similar to those of vancomycin.
The trials also showed that more patients treated with fidaxomicin had a sustained response 3 weeks after treatment ended than patients treated with vancomycin. The most common adverse effects included nausea, vomiting, headache, abdominal pain, and diarrhea.
In April this year, upon reviewing results of the 2 studies, the FDA's Anti-Infective Drugs Advisory Committee unanimously recommended fidaxomicin for the treatment of life-threatening C difficile–associated diarrhea.
"In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a C difficile infection," noted Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a news release. "[Fidaxomicin] is an effective new treatment option for patients who develop Clostridium difficile–associated diarrhea."
Fidaxomicin should be taken 2 times a day for 10 days with or without food and should be used to treat only infections that are proven or strongly suspected to be caused by C difficile.
According to the FDA, C difficile is a bacterium that can cause diarrhea and result in serious intestinal conditions, such as colitis and in some cases death. "C. difficile bacteria are found in the stool of an infected person, and others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouths," the FDA states.

courtesy: http://www.medscape.com/