Latest News

FMT in a pill: FDA approves second product to prevent C. diff recurrence


 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

Pages

Recommended Reading

Does CRC risk in IBD extend to close family members?
MDedge Family Medicine
Celiac disease appears to double COVID-19 hospitalization risk
MDedge Family Medicine
Cannabis tied to lower IBD mortality, hospital costs
MDedge Family Medicine
IBD: More patients on vedolizumab vs. anti-TNFs at 2 years
MDedge Family Medicine
Mental health risks higher among young people with IBD
MDedge Family Medicine
COVID raises risk for long-term GI complications
MDedge Family Medicine
Ulcerative colitis cases projected to top 2 million in eight countries by 2031
MDedge Family Medicine
Upadacitinib shows positive endoscopic outcomes in Crohn’s disease at 1 year
MDedge Family Medicine
FDA approves new formulation of Hyrimoz adalimumab biosimilar
MDedge Family Medicine
Clinical Practice Update: Alpha-gal syndrome often causes GI issues without anaphylaxis, skin changes
MDedge Family Medicine