Disc Medicine, Inc. · 完整回复函 (NDA 220707)

FDA 于 2026-02-13 就 NDA 220707 签发了完整回复函。

关键事实

申报时间: 2026年2月13日 00:00
事件: 完整回复函 (CRL)
方向: 消极
公司: IRONDisc Medicine
资产: bitopertin
来源: openFDA
可信度: 有来源

来源摘录

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

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