Disc Medicine, Inc. · tam yanıt mektubu (NDA 220707)

FDA, NDA 220707 için 2026-02-13 tarihli tam yanıt mektubu yayınladı.

Temel olgular

Bildirildi: 13 Şub 2026 00:00
Olay: Tam yanıt mektubu (CRL)
Yön: Olumsuz
Şirket: IRONDisc Medicine
Varlık: bitopertin
Kaynak: openFDA
Güvenilirlik: Kaynaklı

Kaynak alıntısı

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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