一次情報の記録
決定級審査完了報告書 (CRL)
Disc Medicine, Inc. · 完全回答書 (NDA 220707)
FDA issued a complete response letter for NDA 220707 dated 2026-02-13.
主要事実
- 提出
- 2026年2月13日 00:00
- イベント
- 審査完了報告書 (CRL)
- 方向
- ネガティブ
- アセット
- bitopertin
- 出典
- openFDA
- 信頼度
- 出典あり
出典の抜粋
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