Merck provided substantial evidence of safety and effectiveness for the approval of bezlotoxumab in June 2016 to the FDA, and the administration’s Antimicrobial Drugs Advisory Committee voted 10 to 5 with 1 abstention to recommend its approval. In October 2016, bezlotoxumab commercialized as Zinplava, got approved by the panel. Zinplava is a selective, human immunoglobulin G monoclonal antibody designed to neutralize C. difficile toxin B.
Toxin B can damage the gut wall and cause inflammation, leading to the symptoms of C. difficile enteritis, which include abdominal pain and watery diarrhea. This infection is basically caused by bacteria and occurs...
