Disc Medicine, Inc. is seeking accelerated approval from the FDA for bitopertin to treat patients aged 12 and older with erythropoietic protoporphyria (EPP), including X-linked protoporphyria (XLP). The Commissioner’s National Priority Voucher program aims to reduce the drug application review process to just 1-2 months, offering benefits such as enhanced communication and rolling review. EPP is a rare, debilitating disease caused by mutations affecting heme biosynthesis, leading to severe reactions when exposed to sunlight. Bitopertin is an investigational GlyT1 inhibitor designed to modulate heme biosynthesis and potentially be the first disease-modifying therapy for EPP.

Read more at GlobeNewswire: Disc Medicine Announces Receipt of FDA Commissioner’s