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C. difficile vaccine gets fast-track designation

Issue: December 2010

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The FDA has granted an investigational Clostridium difficile vaccine candidate fast-track designation for the treatment of C. difficile.

“Our C. difficile vaccine candidate is in phase 2,” Michel DeWilde, PhD, senior vice president of research and development at Sanofi-Pasteur, said in a press release. “The FDA fast-track designation recognizes that a C. difficile vaccine could address an important unmet medical need.”

The incidence of C. difficile infection has increased significantly in recent years in North America and Europe. Treatments in these two regions of the world are estimated to be costing more than $7 billion a year. The current treatment of C. difficile infection involves the use of one of the two antibiotics recommended for the management of C. difficile.

Under this program, the FDA can accept for review completed portions of the licensing application before receipt of the entire application, according to DeWilde.