Dificlir (Astellas/Optimer Pharma) is EU approved for Clostridium difficile

Dificlir (fidaxomicin)from Astellas and Optimer Pharma is EU approved for the treatment of Clostridium difficile infections, which can cause severe diarrhoea. The decision is based on two Phase III trials which compared the drug with oral vancomycin, a common antibiotic used to treat CDI and showed that Dificlir was as effective as vancomycin in treating CDI and had a significantly lower rate of recurrence (including relapses) compared to vancomycin in the 30 days following treatment. The FDA approved Dificid (US name) in May 2011. Related Links CHMP backs new superbug drug and expands Bayer s Xarelto FDA OKs Optimer s Clostridium difficile drug Astellas signs antibiotic deal with Optimer The first-in-class macrocyclic antibiotic was approved in the USA in May, where it is sold as Dificid and has got off to a reasonable start. It posted sales of $10.6 million for its first quarter on the market across the Atlantic.