Optimer Pharmaceuticals, Inc. launched Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in patients 18 years of age and older.
In two large Phase 3 clinical studies, Dificid had clinical response rates at the end of the 10-day treatment period that were non-inferior to oral vancomycin. In addition, Dificid was superior to vancomycin in sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment.
Dificid is the only FDA-approved treatment for CDAD that has demonstrated superiority to vancomycin in sustained clinical response and the first new drug approved for the treatment of CDAD in more than 25 years.
Optimer also has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for approval of fidaxomicin, and has entered into an exclusive collaboration and license agreement with Astellas Pharma Europe Ltd. to develop and commercialize the drug in Europe and certain other countries.
Release Date: July 18, 2011
Source: Optimer Pharmaceuticals, Inc.
Filed Under: Drug Discovery
