FDA approves Dificid for C. difficile treatment in children

The FDA has approved Dificid tablets and oral suspension for the treatment of Clostridioides difficile-associated diarrhea in pediatric patients aged older than 6 months, according to a news release.

The approval is based on a phase 3 study in which Dificid (fidaxomicin, Merck) showed improved efficacy compared with vancomycin in pediatric patients with C. difficile. Fidaxomicin tablets were previously approved for the treatment of C. difficile-associated diarrhea in adults aged older than 18 years,

“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,” Larry K. Kociolek, MD, associate medical director of infection prevention and control at Ann and Robert H. Lurie Children’s Hospital of Chicago, said in a news release. “The fidaxomicin pediatric trial was the first randomized controlled trial of C. difficile infection treatment in children. I am very excited to have a new C. difficile infection treatment option for my pediatric patients.”

According to the CDC, C. difficile causes almost half a million illnesses in the United States each year, and one in five infected patients will be infected again. Infection commonly occurs after a person receives antibacterial drugs or has an extended hospital stay.

Fidaxomicin should be used only to treat infections that are strongly suspected or proven to be caused by C. difficile to reduce the development of drug-resistant bacteria, Merck said.

Reference:

Merck. FDA approves Merck’s Dificid (fidaxomicin) to treat Clostridioides difficile in children aged 6 months and older. https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-dificid-fidaxomicin-treat-clostridioides

Disclosure: Infectious Diseases in Children was unable to confirm Kociolek’s relevant financial disclosures at the time of publication.