FDA accepts sNDA for Dificid in children with C. difficile

The FDA accepted a new drug application for the oral suspension formulation of Dificid, Merck’s macrolide antibiotic. At the same time, it accepted a supplemental new drug application for the drug in tablet and oral suspension form for the treatment of Clostridioides difficile infection in children aged 6 months or older, Merck announced.

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

A study published in The New England Journal of Medicine highlighted nearly half a million infections in 2011 alone, and the CDC reported that an estimated 15,000 deaths are attributable to C. difficile.

According to Merck, both applications received priority review by the FDA. The pediatric indications were based on results from the phase 3 SUNSHINE study presented last year at IDWeek. In this analysis, fidaxomicin demonstrated comparable safety and initial efficacy to vancomycin, but patients who received fidaxomicin were significantly more likely to be cured of infection.

The manufacturer noted that fidaxomicin should only be used when C. difficile infection is proven or strongly suspected to prevent the development of drug resistance and maintain its efficacy. – by Katherine Bortz

References:

CDC. Healthcare-associated infections: Clostridioides difficile. https://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html. Accessed Oct. 2, 2019.

Lessa FC, et al. N Eng J Med. 2015;doi:10.1056/NEJMoa1408913.

Wolf J, et al. Abstract LB12. Presented at: IDWeek; Oct. 3-7, 2018; San Francisco.

Disclosures: Kartsonis reports he is an employee of Merck.