미국 FDA 허가 심사자료를 토대로 본 마이크로바이옴 기반 치료제 개발의 전략적 접근

• 영문명: A Strategic Approach to Developing Microbiome-Based Therapeutics Based on US FDA Approval Documents
• 발행기관: 대한약학회
• 저자명: 장수영(Sooyoung Jang) 김종원(Jongwon Kim) 권경희(Kyenghee Kwon)
• 간행물 정보: 『약학회지』제68권 제3호(2024년), 159~167쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2024.06.30

국문 초록

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.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Microbiome-based therapeutics Fecal microbiota transplantation Live biotherapeutics product Clostridioses difficile