G-BA finds Dificlir (Astellas) provides considerable benefit for Clostridium Infection

The Federal Joint Committee (G-BA) of Germany has recognised a "proof of a considerable additional benefit" for Dificlir (fidaxomicin), from Astellas, in patients with severe and/or recurrent Clostridium difficile Infection (CDI) in comparison to therapy with vancomycin, the current standard of care.

Dificlir received European marketing authorisation in December 2011 and was launched in Germany in January 2013. The EU approval was based on two Phase III clinical studies comparing the efficacy and safety of 400mg/day oral Dificlir with 500mg/day oral vancomycin for a treatment period of 10 days in adults with CDI.