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The FDA has approved the fully human monoclonal antibody bezlotoxumab (Zinplava – Merck) for use with antibacterial drug treatment to reduce recurrence of Clostridium difficile infection (CDI) in adults with CDI at high risk for recurrence. It is the first drug to be approved for this indication.
CDI — CDI is the most common infectious cause of healthcare-associated diarrhea in adults. The incidence and severity of CDI have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027).1 The recurrence rate after an initial episode of CDI is typically 20-25%. Patients who develop one recurrent episode have up to a 35% chance of having another one, and patients with at least three CDI episodes have up to a 65% chance of additional recurrences.2
STANDARD TREATMENT —... more
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- Z Yang et al. Mechanisms of protection against Clostridium difficile infection by the monoclonal antitoxin antibodies actoxumab and bezlotoxumab. Infect Immun 2015; 83:822.
- MH Wilcox et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection. N Engl J Med 2017; 376:305.
- V Prabhu et al. Bezlotoxumab decreases CDI recurrence and is associated with a reduction in 30-day readmissions: European analysis. Presented at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Amsterdam, The Netherland, April 9-12, 2016. Abstract P1340.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. March 5, 2017. Reprinted with permission by First Databank, Inc. All rights reserved. ©2017. www.fdbhealth.com/policies/drug-pricing-policy.