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

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

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

Click here ­to­ read full press release/ article | Ref: Merck | Image: Merck

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Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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