New C. difficile drug is one step closer to approval
A new antibiotic designed to treat the diarrhea that accompanies Clostridium difficile won unanimous support from a government medical panel convened by the U.S. Food and Drug Administration.
C. difficile, which afflicts more than 700,000 people in the United States each year, is a particular scourge among hospitals and long-term care facilities. The FDA does not have to agree with the advisory panel's recommendations, though it usually has in the past. The antibiotic, called DIFICID™ (fidaxomicin) is manufactured by San Diego-based Optimer Pharmaceuticals. If approved by the FDA, DIFICID would be the only antibiotic, next to vancomycin, that is FDA-approved for the treatment of C. difficile. An FDA decision on approval of the drug is expected by May 30.
Optimer's research shows that DIFICID is better than vancomycin at preventing recurrences of C. difficile. In previous studies, recurrence happened in 15% of patients treated with DIFICID and in 25% of patients treated with vancomycin. Optimer and Cubist Pharmaceuticals, Inc. yesterday announced the signing of a two-year co-promotion agreement to market DIFICID in the United States.