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news.The US Food and Drug Administration (FDA) has granted fast track designation to Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).
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Currently, PF-06425090 is in Phase II clinical development and it is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.
FDA fast track status will expedite the review of new drugs and vaccines intended for teh treatment or prevention of serious conditions and address an unmet medical need.
C. difficile is the most frequent cause of healthcare-associated infections and currently there is no vaccine available for the prevention of this infection-associated disease.
It is a spore-forming, Gram-positive anaerobic bacillus that produces two exotoxins toxin A and toxin B.
In the US, there are about 250,000 cases of C. difficile-associated disease, resulting in around 14,000 deaths each year.
C. difficile is a common cause of antibiotic-associated diarrhea (AAD) and accounts for 15-25% of all episodes of AAD.