FDA Authorizes A Fecal Microbiome Drug For First Time
In a first that opens the doors for future approvals of such drugs, the Food and Drug Administration approved Ferring Pharmaceutical's therapy that uses bacteria from stool samples to treat a bowel disorder.
Reuters:
U.S. FDA Gives First-Ever Approval To Fecal Transplant Therapy
The U.S. health regulator on Wednesday approved Switzerland-based Ferring Pharmaceuticals' fecal transplant-based therapy to reduce the recurrence of a bacterial infection, making it the first therapy of its kind to be cleared in the United States. The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. In the United States, the infection is associated with 15,000-30,000 deaths annually. (11/30)
Stat:
FDA Approves First Fecal Microbiome Drug, Setting Stage For Others
Rebyota has been in development for about a decade; a key Phase 1 study was first posted to ClinicalTrials.gov in 2013. That decade hasn’t been entirely smooth sailing for microbiome therapeutics. Although investors were intrigued by bacteria-based drug candidates in the early 2010s, interest dropped sharply in 2016 after a significant clinical trial failed. But the field did recover — and patient advocates, drug developers and even regulators have been anticipating this day for years. (Sheridan and DeAngelis, 11/30)
More on C. diff —
Forbes:
Learn To “See” C. Difficile To Protect Yourself From This Serious Infection
C. diff is a bacterial infection you’ve likely never heard of, although it causes almost half a million infections in the US yearly. Half of those with Clostridioides difficile, as it is formally called, require hospitalization, and if you are over 65, 10% die. It’s the most common cause of healthcare-associated infection but is increasingly seen in the community. Recurrences are common, plaguing at least 20% of patients. (11/28)
Health News Hub:
4 Reasons To Take Your Shoes Off Before Coming Indoors
Experts estimate that up to 40% of the contaminants in our home were brought in from the outside. For comparison, University of Houston research examined swabs of shoe bottoms and toilet seats, finding that the shoes had higher levels of C.diff, a bacteria resistant to antibiotics. (McDonald, 11/29)
