US FDA approved fidaxomicin oral suspension for clostridioides difficile-associated diarrhoea (CDAD) in children aged six months and older

Approval is based on the phase III SUNSHINE trial (n=148) comparing fidaxomicin vs vancomycin which reported 77.6% Confirmed Clinical Response at end of treatment+2 Days (primary outcome) vs 70.5% respectively (difference 7.5%, 95% CI; -7.4 to 23.9).

SPS commentary:

The CHMP of the European Medicines Agency has issued a positive opinion recommending approval of fidaxomicin oral suspension for this indication/population (December 2019).


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