FDA Approval of Microbiome-Based Therapy Expands Access for Patients. OpenBiome Continues Distribution of Investigational Fecal Microbiota Transplantation (FMT)
CAMBRIDGE, MA — On November 30th, The U.S. Food and Drug Administration announced the approval of the first microbiome-based therapeutic for recurrent C. difficile. This major milestone is a win for patients who will now have access to additional treatment options and for the microbiome field that is developing new approaches to address unmet medical needs. OpenBiome congratulates the dedicated team behind REBYOTA™ for their achievement.
OpenBiome will continue operating normally and remains committed to providing continued access to investigational fecal microbiota transplantation (FMT) for C. difficile patients not responsive to standard therapies. We and our partner, the University of Minnesota (UMN) Microbiota Therapeutics Program, are working with FDA to ensure that our regulatory filings are consistent with recently finalized guidance.
OpenBiome commends the FDA’s stewardship of investigational FMT through enforcement discretion. This policy has successfully balanced access to treatment and enabling innovation in microbiome therapeutics. Since 2012, OpenBiome has provided over 65,000 rigorously screened investigational FMT preparations to patients with no other treatment options while also collecting safety and efficacy data that has supported the development of FDA-approved therapeutics. We look forward to working with the FDA under a new regulatory paradigm to continue meeting the needs of C. difficile patients that are not eligible for or do not respond to standard therapies.
“It’s exciting that patients will have access to a new FDA-approved therapeutic,” said Dr. Colleen Kelly, associate professor of medicine at Brown University. “But investigational FMT will remain an important option, especially to fill the gap between now and when new therapeutics are widely accessible, and for patient groups who will be ineligible for these new treatments.”
OpenBiome will also continue to work with the American Gastroenterological Association (AGA) on the FMT patient registry to collect valuable long-term outcomes data to inform clinical practice and improve patient care. This important long-term outcomes data will add to a 5,344-patient cohort study that demonstrated a 78% real-world cure rate across all delivery modalities and C. difficile infection subtypes treated with OpenBiome investigational preparations.
Note: This press release was updated on August 7, 2023
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OpenBiome accelerates bold discoveries in microbiome science to improve health for all. An independent nonprofit, we catalyze cutting edge research, advance treatment, and expand scientific capacity to unlock the full potential of the human microbiome.
Since our founding at MIT in 2012, we have provided investigational FMT treatments to more than 65,000 patients with recurrent C. difficile infections and supported over 40 studies investigating how the microbiome affects human health. Through OpenBiome’s new flagship program, the Global Microbiome Conservancy (GMbC), we are building and sharing the world’s most globally representative collection of microbiome samples and strains to fill critical gaps in microbiome science.
For more information, visit www.openbiome.org.