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.
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