By Marie Rosenthal
Although the vote was far from unanimous, the FDA’s Antimicrobial Drugs Advisory Committee recommended approval of bezlotoxumab (Zinplava, Merck) to prevent the recurrence of Clostridium difficile infection (CDI) in patients aged 18 years and older, even though the FDA reviewer disagreed with Merck’s analysis of the study end points.
Cheryl Dixon, PhD, a statistical reviewer at the FDA’s Center for Drug Evaluation and Research, said there was “concern as