Disc Medicine, Inc. · 完整回應函 (NDA 220707)

FDA 於 2026-02-13 針對 NDA 220707 發出完整回應函。

關鍵事實

申報時間: 2026年2月13日上午12:00
事件: 完整回覆函 (CRL)
方向: 負面
公司: IRONDisc Medicine
資產: bitopertin
來源: openFDA
可信度: 有出處

來源摘錄

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

openFDA