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Pfizer Inc. (PFE)’s Investigational Vaccine Candidate For Clostridium Difficile Receives FDA Fast Track Designation


8/28/2014 10:46:47 AM

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NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) 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.1”

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