1차 출처 기록
결정급보완요구서한 (CRL)
Disc Medicine, Inc. · 완전응답서한 (NDA 220707)
FDA가 2026-02-13일자 NDA 220707에 대한 완전응답서한을 발행했습니다.
핵심 사실
- 제출
- 2026년 2월 13일 AM 12:00
- 이벤트
- 보완요구서한 (CRL)
- 방향
- 부정적
- 출처
- openFDA
- 신뢰도
- 출처 확인
출처 발췌
PN U.S. FOOD & DRUG ADMINISTRATION NDA 220707 COMPLETE RESPONSE Disc Medicine, Inc. Attention: Steve Caffé, MD Chief Regulatory Officer 321 Arsenal Street, Suite 101 Watertown, MA 02472 Dear Dr. Caffé: Please refer to your new drug application (NDA) or bitopertin oral tablets. We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues. CLINICAL/BIOSTATISTICS ou submitted NDA 220707 for bitopertin for , Proposing the primary biomarker endpoint of percen’ ole blood metal-free protoporphyrin IX (PPIX) as a surrogate endpoint that is reasonably likely to predict clinical benefit. In