FDA fast-tracks C. difficile vaccine
Sanofi-Pasteur vaccine is currently in Phase II trials
The US Food and Drug Administration (FDA) has fast-tracked a new vaccine aimed at preventing Clostridium difficile infections.
The decision means that the vaccine, developed by Sanofi-Pasteur, the vaccines division of sanofi-aventis, could address an area of unmet medical need.
The number of cases of Clostridium difficile infection (CDI) in North America and Europe has increased significantly in recent years, with the US alone reporting 500,000 cases. CDI-related treatments in these two regions are estimated to be costing more than US$7bn a year.
C. difficile is among the most common cause of hospital-acquired infection in the two regions. Current treatment of C. difficile infection involves the use of one of the two antibiotics recommended for CDI management, but more virulent strains of the bacteria are causing concern.
Sanofi-Pasteur’s non-antibiotic C. difficile vaccine uses a toxoid-based approach, which has been used extensively in licensed vaccines against tetanus, diphtheria and whooping cough.
According to Michel DeWilde, senior vice president of research and development at Sanofi-Pasteur, the vaccine is currently in Phase II trials.
‘The FDA fast-track designation recognises that a C. difficile vaccine could address an important unmet medical need. Under this programme the FDA can accept for review completed portions of the licensing application prior to receipt of the entire application,’ he explained.