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FDA reviewers question efficacy of Merck's bezlotoxumab

June 8, 2016 1:06 AM UTC

In briefing documents released ahead of an advisory committee meeting to discuss an NDA for bezlotoxumab ( MK-6072) from Merck & Co. Inc. (NYSE:MRK) to prevent recurrences of Clostridium difficle infection, FDA reviewers said there "appears to be a decrease" in recurrence rates following a single IV infusion of the candidate, but questioned whether bezlotoxumab's efficacy has been adequately demonstrated. Bezlotoxumab is a human mAb targeting C. difficile toxin B ( TcdB).

At issue are the primary endpoints of the Phase III MODIFY I and MODIFY II studies. Last September, Merck said bezlotoxumab led to significantly lower infection recurrence rates vs. placebo, meeting both trials' primary endpoints (see BioCentury Extra, Sept. 21, 2015). ...