FDA Advisors Backs Approval for Merck & Co.'s Infectious Diarrhea Drug

Merck & Co’s experimental drug to treat the most common cause of hospital-associated infectious diarrhea warrants approval, an advisory panel to the U.S. Food and Drug Administration said on Thursday.

The panel voted 10-5, with one abstention, that the drug, bezlotoxumab, was effective in preventing a recurrence of infection with Clostridium difficile, or C. difficile, a germ that causes inflammation of the colon and potentially fatal diarrhea.

The FDA is not obliged to follow the advice of its advisory panels but typically does.

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