The Food and Drug Administration has accepted for review the New Drug Application (NDA) for fidaxomicin for oral suspension (Merck) for the treatment of Clostridium difficile infections. In addition, the Agency will review a supplemental NDA (sNDA) for fidaxomicin tablets (Dificid) and oral suspension for the treatment of pediatric patients aged 6 months or older. Currently, Dificid, a macrolide antibacterial drug, is available only in a tablet formulation for adults ≥18 years for C. difficile-associated diarrhea.  

The sNDA included data from the phase 3 SUNSHINE study, which evaluated the clinical response of fidaxomicin oral suspension or tablets vs vancomycin oral liquid or capsules in pediatric patients with C. difficile-associated diarrhea (N=148). Results from the trial showed improved confirmed clinical response at Day 12 (primary end point; defined as absence of watery diarrhea for 2 consecutive treatment days and remaining well until study drug discontinuation) and other efficacy outcomes with fidaxomicin when compared with vancomycin. 

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“Evidence indicates the increasing incidence of C. difficile-associated diarrhea among hospitalized children,” said Dr Nicholas Kartsonis, senior vice president, Clinical Research, infectious diseases and vaccines, Merck Research Laboratories. “The filings for the pediatric indication for the new investigational oral suspension formulation of Dificid, as well as for Dificid tablets, underscore Merck’s focus and dedication to developing infectious disease treatments for those with unmet needs.”

The FDA has set a Prescription Drug User Fee Act action date for both applications for January 24, 2020.

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