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 Oct. 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.