Dificid fidaxomicin regulatory update
The U.K.'s NICE published a summary of clinical evidence for antibiotic Dificlir fidaxomicin to treat Clostridium difficile infection (CDI) - its approved indication. The report is the first under the committee's new program to publish summaries about selected new medicines that would not otherwise be subject to a complete cost- and clinical effectiveness appraisal. The summaries do not constitute formal NICE guidances.
The summary concludes that Dificlir is non-inferior to vancomycin, the current standard of care, in patients with mild to severe CDI. Dificlir has a similar side effect profile to vancomycin and may have advantages over vancomycin in reducing the rate of recurrence, according to the summary. NICE recommends that the potential benefits of fidaxomicin should be considered alongside the medical need, the risks and its relatively high cost in comparison with other treatments. According to NICE, Dificlir is priced at £1,350 ($2,091) for a 10-day treatment course, compared to £188.27 ($292) for vancomycin for 10 day. ...