FDA approves fidaxomicin for C. difficile-associated diarrhea in pediatric patients

U.S. Food and Drug Administration (FDA) has approved fidaxomicin for C. difficile-associated diarrhea in pediatric patients.

Food and Drug Administration (FDA) approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides difficile-associated diarrhea (CDAD) in children aged six months and older.

The approval is based on results of the SUNSHINE study, a phase 3 clinical trial evaluating the safety and efficacy of fidaxomicin in children from 6 months and older. It was the first randomized controlled trial of C difficile treatment in children.

DIFICID is a macrolide antibacterial medicine indicated in adults and pediatric patients aged 6 months and older for treatment of CDAD. To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridioides difficile (C. difficile). DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID. DIFICID should only be used for the treatment of CDAD. DIFICID is not expected to be effective for treatment of other types of infections due to minimal systemic absorption of fidaxomicin.

"C. difficile is an important cause of health care- and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized controlled trial of C. difficile infection treatment in children," said Dr. Larry K. Kociolek, Associate Medical Director of Infection Prevention and Control at Ann & Robert H. Lurie Children's Hospital of Chicago. "I am very excited to have a new C. difficile infection treatment option for my pediatric patients."

The recommended dose for adults is one 200 mg DIFICID tablet orally twice daily for 10 days, with or without food.

The recommended dose for pediatric patients weighing at least 12.5 kg and able to swallow tablets is one 200 mg DIFICID tablet administered orally twice daily for 10 days. If unable to swallow tablets, pediatric patients may be dosed with DIFICID oral suspension based on weight. DIFICID oral suspension should be administered orally twice daily for 10 days.

No dose adjustment is recommended for patients 65 years of age or older.

No dose adjustment is recommended for patients with renal impairment.The FDA granted priority review for both applications in October 2019.

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Jan 27 Merk press release