FDA: Obtain IND for C. diff treatment
Fecal transplants considered biologic therapy
The Food and Drug Administration (FDA) has now said that clinicians wishing to perform a fecal transplant for treatment of Clostridium difficile will have to obtain an investigational new drug (IND) application.
The fecal microbiota for transplantation, or FMT, therapy involves taking the fecal matter of a healthy person and transplanting it into the gut of an infected patient in order to combat the highly resistant bacteria. The transplanted fecal matter then establishes a healthy colony of bacteria to prevent C. difficile from taking hold in the gut. The experimental procedure is mainly used on patients with recurring C. difficile infections for whom conventional treatments have failed.1
The FDA held a public forum on FMT therapy at the beginning of May at the National Institutes of Health in Bethesda, MD. The agency says it considers FMT to be a biologic, which requires researchers to obtain an IND for the treatment. “Published data from case studies and metaanalyses suggest that the use of fecal microbiota to restore gut flora may be an effective therapy in the management of refractory C. difficile infection,” the FDA says on its website. “However, the efficacy of this intervention has not yet been demonstrated in controlled clinical trials. Such controlled trials are needed to demonstrate the safety and effectiveness of FMT products for C. difficile infection refractory to conventional therapy.”
The use of FMT therapy to treat recurring C.difficile infections has shown promise. A study presented at the 2011 Annual Meeting of the American College of Gastroenterology showed a primary C. difficile cure rate in 91% of patients who received the transplant, and a 98% cure rate in those who were given single-course vancomycin after transplant.1 A Brown University Alpert School of Medicine study showed 92% cure rate in FMT therapy through colonoscopy.2
Researchers will have an emergency number for the FDA to obtain an IND for patients in dire need of the procedure.
References
1. Brandt LJ. Fecal transplantation for the treatment of Clostridium difficile infection. Gastroenterol Hepatol (N Y). 2012 March; 8(3): 191–194.
2. Kelly CR, et al. Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. J Clin Gastroenterol. 2012 Feb;46(2):145-9. doi: 10.1097/MCG.0b013e318234570b.