APRIL 2, 2018

FDA Fast-Tracks FMT Product for C. difficile

By IDSE News Staff

The FDA awarded a fast track designation for CP101, an encapsulated, oral fecal microbiota transplant (FMT) product (Finch Therapeutics Group) derived from healthy human donors. 

It could be the first FDA-approved FMT product for patients with recurrent Clostridium difficile infections, and is currently being evaluated in Finch’s PRISM 3 study.