MSD faces delay in C. diff drug approval as FDA requests more data

pharmafile | July 22, 2016 | News story | Medical Communications, Research and Development |  C diff, FDA, MSD, Merck 

MSD, known as Merck in the US and Canada, has received a setback in its bid to get new C. diff infection treatment, bezlotoxumab, after the US Food and Drug Administration (FDA) requested more data from previously submitted clinical trials.

The additional data and analyses required will not set back the data for final date for approval by three months. The new prescription drug user fee act goal date has been set for October 23^rd.

A meeting of the FDA’s antimicrobial drugs advisory committee had voted 10 to 5 to recommend the drug. Bezlotoxumab, a fully monoclonal lg61/kappa antibody, binds to and neutralises C difficile toxin B, which is likely by preventing it from binding to colonic cells and causing their inflammation.

MSD indicates that it looks forward to continuing to work with the FDA on the review for bezlotoxumab.

Sean Murray