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FDA committee recommends MSD’s c. diff prevention drug

Published on 10/06/16 at 09:23am

The US Food and Drug Administration’s (FDA) antimicrobial drugs advisory committee has voted by 10 to 5, with one abstention, to recommend Zinplava (bezlotoxumab), an investigational biologic for the prevention of Clostrodium difficile (c.difficile).

Bezoltoxumab is a fully monoclonal Ig61/kappa antibody, developed by MSD, that binds to and neutralises C difficile toxin B, likely by preventing it from binding to colonic cells and causing their inflammation.

In clinical trials, the process was complicated by the fact that MSD, called Merck in the US and Canada, hypothesised that actoxumab, an antitoxin A antibody, would also prevent recurrence of the superbug infection and that the two drugs might be more effective together.

Since the drugs were given alongside standard of care antimicrobial medicines, FDA staff voiced concerns that the researchers potentially underestimated the amount of patients who experienced reoccurrence of the infection due to their failure to respond to antimicrobial.

However, the panel’s recommendation by 10 to 5 is encouraging for a decision on regulatory approval. The Prescription Drug User Fee Act action date for the FDA’s review of Zinplava is July 23, 2016.

Dr Nicholas Kartsonis, associate VP of infectious disease clinical research at MSD, says: “We believe that Zinplava has the potential to offer physicians an important new therapy for their patients to help prevent C. difficile infection recurrence. We look forward to continuing to work with the FDA as it completes its review of our Biologics License Application for Zinplava.”

Sean Murray

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