(Reuters) -A panel of U.S. Food and Drug Administration advisers voted in favor of Ferring Pharmaceuticals’ fecal transplant-based therapy to reduce recurrent infections caused by a bacteria known as C. difficile.
The therapy is based on the concept of 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 are working on similar therapies based on fecal microbiota transplantation (FMT), as well as synthetically fermented versions.
While no FMT therapy has yet been approved by the FDA, it has been widely used for patients with recurring C. diff infections under the agency’s “enforcement discretion” provision.
Ferring says that access through that pathway to FMT therapies, however, remains limited, and is not standardized.
Privately-held Ferring acquired the drug through its 2018 purchase of U.S.-based Rebiotix Inc.
(Reporting by Manas Mishra and Raghav Mahobe in Bengaluru; Editing by Shinjini Ganguli)
