FDA Approves Fidaxomicin for C difficile Treatment
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 infectiou...