U.S. FDA panel recommends Ferring's fecal transplant therapy




  • In US
  • 2022-09-22 20:29:59Z
  • By Reuters

(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)

COMMENTS

More Related News

U.S. FDA proposes new rules for packaged foods to qualify as
U.S. FDA proposes new rules for packaged foods to qualify as 'healthy'
  • US
  • 2022-09-28 14:55:41Z

The proposed changes to food labeling come on the day of the first White House summit on hunger, nutrition and health in more than 50 years. Under the new proposal, packaged products will be allowed to carry the "healthy" label subject to them containing a certain amount of food from at least one of the groups, recommended by the current dietary guidelines, with specified limits on saturated fat, sodium and added sugars. More than 80% of the U.S. population has not been eating enough vegetables, fruit and dairy, while consuming unhealthy amounts of added sugars, saturated fat and sodium in their diet, the FDA said.

Bill to Prevent Government Shutdown Released by Senate Democrats
Bill to Prevent Government Shutdown Released by Senate Democrats

(Bloomberg) -- Senate Democrats released a short-term government funding bill late Monday that included a measure to speed up energy project permits that's...

U.S. FDA clears additional lots of Moderna
U.S. FDA clears additional lots of Moderna's Covid booster amid shortage

Last week, the health regulator had allowed use of ten batches of Moderna's updated booster shots made at the Bloomington, Indiana facility, owned by a unit of Catalent Inc, which is currently not a part of the company's emergency use authorization. The FDA had earlier said Moderna had requested authorization for additional batches in light of the current supply issues.

Insider Q&A: FDA official on vaping
Insider Q&A: FDA official on vaping's "promise or peril"

There's been no honeymoon period for the Food and Drug Administration's new tobacco chief, Brian King, the public health scientist now responsible for regulating the nation's multibillion-dollar cigarette and vaping industry. The problems facing FDA's Center for Tobacco Products have only multiplied since King's arrival in July from the Centers for Disease Control and Prevention. The FDA missed a summer deadline to review nearly a million applications for e-cigarettes and other new products that use laboratory-made nicotine, some of which have become popular teenagers.

Leave a Comment

Your email address will not be published. Required fields are marked with *

Cancel reply

Comments

Top News: US