Microbiome Therapeutics Innovation Group Statement on Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
WASHINGTON, March 13, 2020 /PRNewswire/ -- On March 12, 2020, the U.S. Food and Drug Administration (FDA) issued a safety alert regarding the use of fecal microbiota for transplantation (FMT) due to infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC).
The FDA safety alert states six patients who received FMT products from a stool bank company for treatment of Clostridium difficile developed infections caused by EPEC or STEC.
The Microbiome Therapeutics Innovation Group (MTIG) supports the development of therapeutic microbiota-based products that are safe and effective. Our coalition companies are adhering to FDA guidelines for Investigational New Drugs, which include donor screening/testing and/or quality control requirements. MTIG supports the FDA Investigational New Drug regulations for patient access to safe and effective treatments. We look forward to further discussions with the FDA to develop guidelines for the application of pharmaceutical development criteria related to microbiota-based therapeutics and for the evaluation of safety parameters related to microbiota-based therapeutic products.
About the Microbiome Therapeutics Innovation Group
The Microbiome Therapeutics Innovation Group (MTIG) is a coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. MTIG is committed to working with stakeholders who share in our mission and seek tangible policy and regulatory solutions in the emerging microbiome arena. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic product development and enable the field to reach its potential to benefit patients.
Today, the MTIG is comprised of six companies: Rebiotix, Inc., Seed Health, Seres Therapeutics, Siolta Therapeutics, Takeda, and Vedanta Biosciences.
All pharmaceutical and biotechnology companies pursuing regulatory approvals for microbiome therapeutics and microbiome-based products are eligible for consideration of membership in MTIG. If you are interested in learning more about becoming a member, please contact us here.
For more information, visit: www.microbiometig.org
SOURCE Microbiome Therapeutics Innovation Group (MTIG)
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