Disc Medicine Submits NDA to FDA for Bitopertin in Erythropoietic Protoporphyria; Seeks Accelerated and Priority Review

Reuters
09/30
<a href="https://laohu8.com/S/IRON">Disc Medicine</a> Submits NDA to FDA for Bitopertin in Erythropoietic Protoporphyria; Seeks Accelerated and Priority Review

Disc Medicine Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bitopertin, a potential treatment for erythropoietic protoporphyria $(EPP)$ and X-linked protoporphyria $(XLP)$ in patients aged 12 and older. The company is seeking accelerated approval and has requested Priority Review, which, if granted, could shorten the FDA review period to six months following the initial 60-day filing review. Bitopertin has already received Orphan Drug and Rare Pediatric Disease designations from the FDA. No grant or funding was announced in connection with this regulatory submission, and the NDA was submitted solely by Disc Medicine Inc.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Disc Medicine Inc. i published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9537203-en) on September 30, 2025, and is solely responsible for the information contained therein.

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