FDA to Review Merck Antitoxin for Clostridium Difficile
January 27 2016 - 12:49PM
Dow Jones News
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 joshua.jamerson@wsj.com
(END) Dow Jones Newswires
January 27, 2016 13:34 ET (18:34 GMT)
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