ZINPLAVA®? - a new therapy for the prevention of recurrence of Clostridium difficile infection - launched in the UK

From Drug Discovery Today - January 10, 2018

MSD (known as Merck & Co., Inc. in the US and Canada) today announced the UK launch of ZINPLAVA (bezlotoxumab) - a new therapy for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI. Bezlotoxumab is administered as a single, one-off, one-hour intravenous infusion alongside standard-of-care (SoC) antibiotic therapy for the treatment of CDI.

Clostridium difficile (C. difficile) is a bacterium that colonises the bowel and lives in the colon without causing disease in up to 3% of adults.C. difficile produces toxins, (principally toxins A and B) that can lead to damage of the lining of the colon, causing a range of symptoms from mild diarrhoea to perforation of the colon, sepsis and death.

In the financial year 2016/17, there were 12, 840 cases of CDI reported in England. Patients who develop CDI are usually given an antibiotic to treat the infection, but CDI can often come back within weeks or months. For hospitalized patients, the rate of recurrence is around 20% after the first episode and 4560% after a second episode of CDI.journals.plos.org/plosone/articleThe mortality rate of CDI infection can be up to 25% in frail, elderly people in hospitals.Repeat episodes are associated with an increased number of hospitalisations and therefore higher costs.

Antibiotics are used to treat CDI, but they also may further disrupt the gut microbiota, making some patients vulnerable to CDI recurrence.

Mark Wilcox, Professor of Medical Microbiology at the University of Leeds, commented: Bezlotoxumab is the first therapy for CDI that targets the toxin that causes this disease. Notably, bezlotoxumab reduces the risk of the recurrence of CDI for at least 3 months, compared with standard of care antibiotic therapy. This is welcome addition to our limited options to reduce the considerable morbidity and mortality associated with CDI.

Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity. Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin B produced by the outgrowth of persistent or newly-acquired C. difficile spores.Bezlotoxumab is not a treatment for CDI and has no effect on the current CDI episode. The experience with bezlotoxumab in patients is also limited to a single CDI episode and single administration.

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