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 mostly in patients residing in hospitals and nursing homes who might have taken certain antibiotics or some other medications. The incidence of this infection is higher in certain patient populations, including people 65 years of age or older, and in patients with compromised immune systems due to an underlying disease or from treatment.
Zinplava was developed by researchers at UMass Medical School’s Mass Biologics along with Medarex (now part of Bristol-Myers Squibb), and licensed to Merck in 2009 for development as a potential therapeutic for C. difficile infection. After the threat given to the company by eroding Cubicin’s patent protection in court–and the Supreme Court’s decision in May 2016 not to take up the case- this decision has been a much needed achievement for the company. Merck will make Zinplava available in first quarter of 2017.
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