(Reuters) – A panel of U.S. Food and Drug Administration advisers voted in favor of Ferring Pharmaceuticals’ fecal transplant-based therapy to reduce the recurrence of a bacterial infection, bringing the first therapy of its kind closer to approval.
The therapy, Rebyota, works by replenishing the good gut bacteria through samples of microbes distilled from faeces of healthy donors, delivered through an enema in this case.
Besides Switzerland-based Ferring, other companies including Seres Therapeutics, which is developing an oral treatment, are working on similar therapies based on fecal microbiota transplantation (FMT).
Although antibiotics are the first-line of treatment for C. diff, which causes about half a million infections in the United States per year, they can also kill the good gut bacteria that prevent recurrences.
Rebyota targets Clostridium difficile, or C. difficile, a superbug responsible for infections that can cause serious and life-threatening diarrhea.
While no FMT therapy has yet been approved by the FDA, it has become popular for treating recurring C. diff infections under the agency’s “enforcement discretion” provision.
Ferring says that access to FMT therapies, however, remains limited, and is not standardized.
“Right now, patients can get an FMT from their roommates, or if this get approval, they can get a defined FMT that has undergone some sort of quality control,” said Eric Rubin, a panel member who voted “yes”.
Still, the votes were not unanimous and some panel members highlighted a lack of clear data that showed effectiveness against C. diff.
Enrollment challenges led Ferring, which gained the drug through its 2018 purchase of U.S.-based Rebiotix Inc, to scrap one of its two planned late-stage trials.
“This is very limited data,” said Amanda Cohn, who voted in favor but urged the FDA to seek post-marketing data from Ferring if the drug is approved.
(Reporting by Manas Mishra and Raghav Mahobe in Bengaluru; Editing by Shinjini Ganguli)
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