ARTICLE | Clinical News

Dificid fidaxomicin regulatory update

April 11, 2011 7:00 AM UTC

FDA's Anti-Infective Drugs Advisory Committee voted 13-0 that Dificid fidaxomicin from Optimer was safe and effective at treating Clostridium difficile-associated diarrhea (CDAD). However, the panel voted 7-6 that the finding of lower recurrence of CDAD at day 31 vs. Vancocin vancomycin was not clinically significant. Panel members did not feel that the two Phase III trials used to support approval were adequately designed to assess a reduction in disease recurrence or that the 31-day time point was long enough to be considered clinically significant.

In the Phase III studies, Dificid demonstrated noninferiority to Vancocin on the primary endpoint of clinical cure at the end of treatment, and Dificid was superior to Vancocin on the secondary endpoint of global cure rate assessed at day 31. ...