IQWiG finds added benefit for Dificlir in C. difficile infections

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed additional information for two studies comparing Japanese drug major Astellas’ (TYO: 4503) antibiotic Dificlir (fidaxomicin), which is used for diarrhea caused by Clostridium difficile infections, with vancomycin.

In contrast to the first dossier assessment, the Institute now sees proof of a minor added benefit of fidaxomicin versus the appropriate comparator therapy in patients with severe or recurrent disease. An added benefit is still not proven in patients with mild disease; the manufacturer provided no new data for this indication.

Manufacturer dossier did not allow an overall conclusion