Merck & Co’s Dificid (fidaxomicin) Receives FDA’s Approval to Treat Clostridioides difficile in Children Aged Six Months and Older

Shots:

• The US FDA has approved NDA for Dificid oral suspension and sNDA for Dificid tablets for the treatment of Clostridioides difficile-associated diarrhea (CDAD) in patients aged ≥6mos.
• The approval is based on P-III SUNSHINE study assessing Dificid (bid) vs vancomycin (q4d) in 148 patients in a ratio (2:1) aged <18 yrs. with confirmed CDI resulted in CDAD clinical response in the overall pediatric population (77.6% vs 70.5%), CR & no CDAD reoccurrence (68.4% vs 50.0%)
• Merck & Co’s (MSD outside the United States and Canada) Dificid is a macrolide antibacterial medicine indicated in adults and pediatric patients aged≥ 6mos. to treat CDAD and has received the US FDA’s PR status for both applications

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