Pfizer’s C. difficile Vaccine in Phase II gets US FDA Fast Track Status

US Pfizer said Thursday that its investigational Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, had obtained Fast Track status from the US FDA.The vaccine is presently in Phase II clinical development. It is intended for the prevention of C. difficile associated disease, which may include life-threatening diarrhoea and pseudomembranous colitis.

There is currently no vaccine available to prevent C. difficile- associated disease. There are about 250,000 cases of C. difficile- associated disease in the USA, leading to nearly 14,000 deaths annually, senior VP of Pfizer Vaccine R&D, Dr. Emilio Emini, noted.

C. difficile is a spore-forming, Gram-positive anaerobic bacillus producing two exotoxins, toxin A and toxin B. It is a common cause of antibiotic-associated diarrhoea (AAD) and accounts for 15-25% of all episodes of AAD.

28 August 2014

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http://medcitynews.com/2014/08/fda-puts-pfizers-c-difficile-vaccine-fast-track-approval/