The FDA has approved Merck & Co’s bezlotoxumab to reduce the recurrence of Clostridium difficile infection, marking the first approval for a new approach to the treatment of bacterial infections. Unlike antibiotics, which kill pathogenic bacteria, bezlotoxumab is an antibody that mops up toxins that are released by C. difficile.
Although antibiotics can control C. difficile, the infection recurs within weeks in around 25% of patients. In two phase III trials that tested bezlotoxumab in conjunction with standard of care antibiotics, Merck showed that their adjunct antibody reduced recurrence to 16–17% of patients. The most common adverse reactions included nausea, pyrexia and headache.
NATURE REVIEWS | DRUG DISCOVERY VOLUME 15 | DECEMBER 2016 | 811
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