A Strategic Approach to Developing Microbiome-Based Therapeutics Based on US FDA Approval Documents

The development of microbiome-based therapeutics has received considerable attention, as our understanding of the complex interactions between the microbiome and humans deepens. The potential of microbiome-based therapeutics has been proved by the US FDA’s approval of two fecal microbiota transplantation (FMT) products. This study analyzes FDA approval documents of two microbiome-based therapies, RebyotaTM and VowstTM, to identify regulatory science evidence, and to provide insights into the development and regulation direction of Live Biotherapeutic Products (LBPs). Strategic use of expedited review programs to reduce time and cost during the approval process, standardized manufacturing processes to ensure consistent quality and safety, preparation of nonclinical studies tailored to productspecific characteristics, and addressing changing unmet medical needs are essential for successful therapeutic development and rapid market entry. Strategic approaches are essential in the development of microbiome-based therapeutics, and we look forward to the continued application and evolution of these approaches in the future.