FDA fast track designation granted to Clostridium difficile vaccine candidate
Sanofi Pasteur announced that the FDA has granted fast track designation to its investigational Clostridium difficile vaccine candidate. Fast-track designation is granted to those 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. Sanofi Pasteur's C. difficile vaccine candidate is currently in Phase 2.
At this time, the incidence of Clostridium difficile infection (CDI) has increased significantly in recent years in both North America and Europe. The recent emergence and spread of a hyper-virulent strain of C. difficile further highlights the importance of preventing CDI. Current treatment involves the use of one of the two antibiotics recommended for CDI management.
For more information call (800) VACCINE or visit www.sanofipasteur.us.