Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.
“C. difficile is a growing, difficult-to-treat healthcare-associated infection,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “No vaccine is currently available to prevent the infection-associated disease. In the United States alone, there are approximately 250,000 cases of C. difficile-associated disease, resulting in approximately 14,000 deaths each year.”
The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.