FDA to Review Merck Antitoxin for Clostridium Difficile

   Joshua Jamerson 
 

Merck & Co. said Wednesday that the U.S. Food and Drug Administration would review an investigational antitoxin that researchers hope will prevent the recurrence of an illness often passed on to patients by healthcare workers.

Clostridium difficile is a bacterium that causes inflammation of the colon that is typically treated with antibiotics.

The Merck antitoxin, bezlotoxumab, is given in conjunction with standard-of-care antibiotics, and is designed to neutralize C. difficile toxin B, which can damage the gut wall and lead to diarrhea.

The elderly and people who have illnesses or conditions requiring prolonged use of antibiotics are at greater risk of the disease, according to the U.S. Centers for Disease Control and Prevention.

The bacterium is shed in feces. It can contaminate any surface, device, or material--such as toilets, bathing tubs, and electronic rectal thermometers--that comes in contact with feces that serve as a reservoir for C. difficile spores.

The spores, according to the CDC, can be transferred to patients by the hands of healthcare personnel who have been exposed to the bacterium. The disease caused an estimated half million infections in the United States in 2011, and 29,000 died within 30 days of diagnosis.

Dr. Roy Baynes, senior vice president of clinical development at Merck Research Laboratories, said in a statement there are currently no therapies approved for the preventing recurrence of the illness after remission.

Shares of Merck were recently down 0.3% to $51.29.

Writer to Joshua Jamerson at [e-mail]

(END) Dow Jones Newswires

January 27, 2016 13:34 ET (18:34 GMT)

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