메디포스트 카티스템, 美 3상 1개로 끝낸다…'FDA 단일임상 허용'[only 이데일리]

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메디포스트 카티스템, 美 3상 1개로 끝낸다…'FDA 단일임상 허용'[only 이데일리] 03.06.2026

이데일리 (Edaily)

메디포스트의 무릎 골관절염 치료제 '카티스템'이 미국 식품의약국(FDA)의 임상시험 간소화 기조에 따라 임상 3상을 기존 예상 규모의 절반인 약 300명 규모의 단일 피보탈 임상으로 진행하게 되었다. 전통적으로 FDA는 동일한 설계의 두 건의 독립적인 임상을 요구했으나, 2023년 9월 발표된 가이드라인 초안을 통해 단일 임상시험과 보강 증거만으로도 유효성 입증이 가능해지면서 임상 개발 효율화가 추진되고 있다. 카티스템의 경우, 일본 임상 3상에서 확보한 통계적 유의성과 연골 재생 효과 데이터, 그리고 국내 10년 이상의 시판 경험 및 장기 추적 데이터가 FDA 허가 심사 과정에서 보강 증거로 활용될 가능성이 커졌다. 이러한 단일 임상 방식 진행은 개발 비용 절감과 환자 등록 완료 시점 단축에도 기여할 것으로 예상된다.

이데일리 (Edaily) Full Article

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