Merck MRK, known as MSD outside the United States and Canada,
today announced that the two pivotal Phase 3 clinical studies for
bezlotoxumab, its investigational antitoxin for prevention of Clostridium
difficile (C. difficile) infection recurrence, met their
primary efficacy endpoint: the reduction in C. difficile recurrence
through week 12 compared to placebo, when used in conjunction with
standard of care antibiotics for the treatment of C. difficile.
Based on these results, the company plans to submit new drug
applications seeking regulatory approval of bezlotoxumab in the U.S., EU
and Canada in 2015. Currently, there are no therapies approved for the
prevention of recurrent disease caused by C. difficile.
Results from the studies were presented
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