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.
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