FDA Committee Gives Thumbs Up to Merck’s Bezlotoxumab

An FDA advisory committee recommended the approval of Merck’s bezlotoxumab to prevent Clostridium difficile infection recurrence in patients 18 and older.

The advisory committee voted 10-5, with one abstention, to approve the candidate given the safety and efficacy data presented by the sponsor.

Committee members who voted against approval recommended the sponsor further analyze its dataset. They suggested the sponsor study the candidate in younger participants as the proposed indication includes pediatric patients. The mean age of patients enrolled in one of the Phase 3 studies was 64.