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# FDA Accepts Merck BLA for Recurring C. Diff Infection
- URL: https://www.fdaweb.com/fda-accepts-merck-bla-for-recurring-c-diff-infection/
- Published: 2016-01-27T12:00:00.000Z
- Updated: 2026-09-15T02:31:07.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5134581

> FDA has accepted for review a Merck BLA for bezlotoxumab, an investigational antitoxin for preventing Clostridium difficile (C. difficile) infection recurrence. The agency has granted a priority review, with a user fee review target date of 7/23.  
>  
> The submission based in part on data from the pivotal [MODIFY I and MODIFY II clinical trials](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.mercknewsroom.com%2Fnews-release%2Fresearch-and-development-news%2Fpivotal-phase-3-studies-bezlotoxumab-mercks-investigation&esheet=51267244&newsitemid=20160127005220&lan=en-US&anchor=MODIFY+I+and+MODIFY+II+clinical+trials&index=1&md5=76a96e77820e42d20a86d34763eb257c&ref=fdaweb.com). The studies 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.  
>  
> Bezlotoxumab is an investigational antitoxin that is designed to neutralize C. difficile toxin B, a toxin that can damage the gut wall and cause inflammation, leading to C. difficile-associated diarrhea, according to Merck.