The panel voted 10-5, with one abstention, that the drug,
bezlotoxumab, was effective in preventing a recurrence of infection
with Clostridium difficile, or C. difficile, a germ that causes
inflammation of the colon and potentially fatal diarrhea.
The FDA is not obliged to follow the advice of its advisory panels
but typically does.
The panel's vote follows an internal review by FDA staff which found
an apparent decrease in recurrence of C. difficile but expressed
concern as to whether the drug could hurt the cure rate of the
initial C. difficile episode.
Panelists who voted in favor of the drug acknowledged the FDA's
concerns but said they were persuaded there was a need for new
targeted therapies and this one seems effective.
"We haven't had a new drug for C. difficile in our armamentarium for
some time," Dr. Joanna Schaenman, assistant professor of medicine at
UCLA David Geffen School of Medicine, said.
Spores from C. difficile bacteria cling to surfaces and can spread
easily in hospitals and nursing homes. The germ infected nearly
500,000 people in 2011 and killed 15,000, according to the Centers
for Disease Control.
C. difficile is typically treated with antibiotics. But these kill
good bacteria in the gut, setting up a vicious cycle in which low
levels of good bacteria make it more difficult for the body to fend
off the bad C. difficile germ.
Bezlotoxumab is designed to neutralize C. difficile toxin B,
suppressing symptoms long enough for the body's natural flora to
replenish and preventing the need for additional cycles of
[to top of second column]
Still, not all panelists were convinced, saying the drug had been
tested on too few people to be sure it was really helping achieve a
sustained cure, and they worry the drug could even impede a cure.
Dr. Lindsey Baden, director of clinical research at Brigham and
Women's Hospital and the panel's acting chair, said the drug was
promising but so far, "the level of proof is not there yet."
The FDA is due to make its decision by July 23.
(Reporting by Toni Clarke in Washington; Editing by David Gregorio
and Matthew Lewis)
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