First pill for fecal transplants wins FDA approval
Stool in pill form is now available for recurrent Clostridioides difficile (C. diff) infections.
The FDA authorized Vowst, the first oral biologic therapy for fecal microbiota, after clinical trials showed it was as successful as rectally administered transplants. Blood, proteins, bacteria, and other creatures make biologic medications.
FMT involves colonoscopy or retention enema to transfer healthy donor stool into a patient’s colon. The first rectal microbiota product for C. diff patients was FDA-approved late last year.
C. diff, typically caught from antibiotics, produces severe diarrhea, stomach pain, fever, and organ failure. According to the CDC, one in six individuals have recurrent infections within two to eight weeks. Recent hospital or nursing home stays, low immune systems, and C. diff infections increase risk.
In a news release, FDA Center for Biologics Evaluation and Research director Dr. Peter Marks said:
“The oral fecal microbiota product is a significant step forward in advancing patient care and accessibility for individuals who have experienced this potentially life-threatening disease.”
Vowst—four tablets for three days—is risky. Before manufacturing, donated human feces is tested for transmissible diseases. The tablet may contain pathogenic germs and food allergies from donor faeces, according to the news release. Such allergies may trigger Vowst responses.
She warned that solving one problem may create others. “We must monitor these patients carefully to avoid other issues.”
The medicine received Priority Review, Breakthrough Therapy, and Orphan classifications from the FDA, according to a news release.
Hazan said donor stool businesses must test for COVID-19 because there is no FDA-approved screening test. Forensics isolates the virus.
She also expressed concern that donor stool’s health isn’t regulated. Hazan’s patients select their own donors, usually family members. All donor health conditions are mentioned.
The new drug may work. Hazan said using excrement to cure illnesses and diseases is insane, but the C. diff findings are astounding.
“Approving this advances the field,” she said. It should go well, be safe, and not cause any issues. The clinic is different from clinical trials.”
