FDA Approves Merck's Zinplava to Reduce C. difficile Recurrence in Patients


The US Food and Drug Administration has approved Merck’s Zinplava, a monoclonal antibody that will reduce recurrence of Clostridium difficile in high risk patients.

In a recent announcement, Merck, a global pharmaceutical company, reported that the US Food and Drug Administration (FDA) has given the green light to the drug Zinplava, (bezlotoxumab). Zinplava can be used to reduce the chance of Clostridium difficile infection (CDI) from recurring in high risk patients 18 years of age or older who are currently being treated for CDI with antibacterial drugs.

Nicholas Kartsonis, MD, vice president of clinical development, infectious diseases, at Merck Research Laboratories commented, “For generations, Merck has been steadfast in its commitment to fighting infectious diseases-and that commitment continues today. Zinplava is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects.”

Zinplava is the result of a collaborative effort between University of Massachusetts Medical School’s MassBiologics and Medarex researchers. Developers designed Zinplava as a way to “neutralize” bacteria-producing toxins, such as toxin B, which could result in severe C. difficile small bowel enteritis. Zinplava is not an antibiotic and should only be used in tandem with antibacterial drugs used to treat CDI.

In a recent press release by the University of Massachusetts Medical School, Mark Klempner, MD, executive vice chancellor for MassBiologics and professor of medicine, commented, “Discovering and developing effective new treatments for vexing public health threats has been the mission of MassBiologics since its founding more than 120 years ago. It is exciting and satisfying that all of the creative, hard work of our UMMS faculty and staff has led to this important advance for the treatment of this serious infectious disease.”

Clostridium difficile remains a public health concern, with the Centers for Disease Control and Prevention reporting that this particular infection is the cause of around half a million infections within the United States alone, with 29,000 of these cases resulting in death. A common healthcare-associated infection, the symptoms associated with C. diff and its recurrence can range from mild to severe. Patients who are most at risk include people who are 65 or older as well as those who are immunocompromised.

According to the University of Massachusetts press release, “Recurrence is a major challenge in C. difficile infection, with approximately one in four patients experiencing a recurrence after the initial episode, and more than 40 percent of these patients having further C. difficile recurrence.”

Merck estimates that Zinplava will be available on the market in 2017.

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