22 July 2016 - Merck today said that the U.S. FDA has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending biologics licensing application for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence.

The additional data and analyses constitute a major amendment to the biologics licensing application (BLA), resulting in an extension of the Prescription Drug User Fee Act goal date by three months. The new goal date will be October 23, 2016.

The FDA granted Priority Review designation to the bezlotoxumab BLA, with an original PDUFA goal date of July 23, 2016. On June 9, the Antimicrobial Drugs Advisory Committee of the FDA voted 10-to-5, with one abstention, in support of bezlotoxumab as showing substantial evidence of efficacy and safety in preventing the recurrence of C. difficile infection.

Merck looks forward to continuing to work with the FDA on the review of the bezlotoxumab BLA.

Read Merck press release