U.S. FDA Grants Fast-Track Designation to Sanofli Pasteur's Investigational Clostridium difficile Vaccine

By:  Sanofli Pasteur

09 November 2010

SWIFTWATER, Pennsylvania, November 9, 2010 /PRNewswire via COMTEX/ — Sanofi Pasteur, the vaccines division of sanofi-aventis Group , announced today that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to the company’s investigational Clostridium difficile vaccine candidate. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

The incidence of Clostridium difficile infection (CDI) has increased significantly in recent years in both North America and Europe. CDI-related treatments in these two regions of the world are estimated to be costing more than $7 billion a year. The recent emergence and spread of a hyper-virulent strain of C. difficile further highlights the importance of preventing CDI.

C. difficile is among the most common causes of nosocomial (hospital-acquired) infection in North America and Europe. Current treatment of C. difficile infection involves the use of one of the two antibiotics recommended for CDI management.

Read the entire press release here.

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