U.S. regulatory panel backs approval for Merck C. difficile drug

Merck Co’s experimental drug to treat the most common cause of hospital-associated infectious diarrhea warrants approval, an advisory panel to the U.S. Food and Drug Administration said on Thursday.

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 negatively affect 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.

The FDA is due to make its decision by July 23.

(Reporting by Toni Clarke in Washington; Editing by Andrew Hay and David Gregorio)