FDA approves Dificid for oral suspension and for children aged 6 months and over to treat Clostridioides (formerly Clostridium) difficile-associated diarrhea.-Merck Inc.+ Astellas

Merck Inc., announced the FDA has 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 (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.

The FDA�s approval of the new formulation and new indication for Dificid was based on a Phase III, multicenter, investigator-blind, randomized, parallel group study (known as the SUNSHINE study, NCT02218372) in which the safety and efficacy of fidaxomicin was evaluated in pediatric patients from 6 months to less than 18 years of age (one patient was less than six months of age). This study, sponsored by Astellas Pharma Europe B.V. (with Merck & Co., Inc. as collaborator) included 148 randomized patients aged <18 years with confirmed cdi, of whom 142 received either fidaxomicin (suspension or tablets, twice daily) or vancomycin (suspension or tablets, four times daily) in a 2:1 ratio. patients were randomized by age group, as follows: 30 patients from 6 months to><2 years; 49 patients age 2 to><6 years, 40 patients age 6 to><12 years and 29 patients age 12 to><18 years. generally, the two treatment groups were balanced regarding demographics and other baseline characteristics. cdad clinical response in the overall pediatric population, assessed through two days following 10 days of treatment, was similar between the fidaxomicin and vancomycin groups (77.6% vs. 70.5% with a 95% ci for the treatment difference of 7.5 [-7.4%, 23.9%]). sustained clinical response, defined as the proportion of treated patients with confirmed clinical response and no cdad recurrence through 30 days after the end of treatment, was higher for fidaxomicin than for vancomycin (68.4% vs. 50.0% with a 95% ci for the treatment difference of 18.4 [1.5%, 35.3%]).>