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The European Commission Grants Marketing Authorization for DIFICLIR™ (fidaxomicin) Tablets for Treatment of Clostridium difficile Infections
Date:12/12/2011

rth America (US and Canada). The second Phase 3 study was carried out in 535 subjects in North America and Europe.  Of the subjects enrolled in these studies, 47.9% were 65 years or older and 27.5% were treated with concomitant antibiotics. Both studies met their primary endpoint of non-inferiority, demonstrating that the proportion of subjects in whom clinical cure was achieved at the end of 10 days was similar for both DIFICLIR and oral vancomycin. In both trials DIFICLIR proved to have a statistically significantly lower rate of recurrence of CDI as compared to oral vancomycin 30 days after the end of treatment.  The most common treatment related adverse reactions were vomiting (1.2%), nausea (2.7%) and constipation (1.2%).

DIFICLIR is described in the EU label as a narrow spectrum antimicrobial drug with bactericidal activity against C. difficile and inhibitory activity against C. difficile sporulation in-vitro. Fidaxomicin, the active ingredient in DIFICLIR, is a member of a new class of antibacterials called macrocycles.

Astellas Pharma Europe Ltd. is Optimer's exclusive licensee to develop and commercialize DIFICLIR in Europe and additional countries in the Middle East, Africa and the Commonwealth of Independent States.

The Summary of Product Characteristics, including the DIFICLIR product label, can be accessed directly from the EMA website at http://www.ema.europa.eu .

About CDI

Clostridium difficile infection (CDI) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDI is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum anti
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SOURCE Optimer Pharmaceuticals, Inc.
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