Pfizer Inc. (PFE) Thursday said the U.S. Food and Drug Administration or FDA has granted Fast Track designation to the company's investigational Clostridium difficile vaccine candidate. The candidate is currently in its Phase 2 stage of clinical development and is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.
The Fast Track designation facilitates the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
Dr.Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer said: "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."
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