Regulatory Considerations in Commercializing a Non-Antibiotic Microbiota-Based Drug Targeted for Recurrent Clostridium difficile Infection

Background

Clostridium difficile infection is the leading cause of healthcare acquired diarrhea, and is linked to perturbations of the intestinal microbiota initiated by antibiotics. Approximately, 20% to 30% of patients will go on to experience recurrence, with each additional episode predisposing to further recurrence. No drug is currently indicated for recurrent Clostridium difficile infection.