Disc Medicine, Inc. · carta de resposta completa (NDA 220707)

A FDA emitiu uma carta de resposta completa para o NDA 220707 datada de 2026-02-13.

Fatos principais

Arquivado: 13 de fev. de 2026, 00:00
Evento: Carta de resposta completa (CRL)
Direção: Negativo
Empresa: IRONDisc Medicine
Ativo: bitopertin
Fonte: openFDA
Confiança: Com fonte

Trecho da fonte

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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