FDA Seeks More Data on Merck BLA for Bezlotoxumab

FDA has asked Merck to submit new data and analyses from the clinical trials MODIFY I and MODIFY II that support a pending BLA for bezlotoxumab, an investigational agent for preventing Clostridium difficile (C. difficile) infection recurrence. The additional data and analyses will be considered a major amendment, resulting in a three-month user fee review extension. The new review goal date will be 10/23.

Merck had earlier said the pivotal MODIFY I and MODIFY II clinical trials 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.