FDA delays decision on Merck's bezlotoxumab

US pharma giant Merck & Co (NYSE: MRK) says that the US Food and Drug Administration 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 (BLA) 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 BLA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) 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.