Also known as: percent change in whole blood metal-free PPIX
The FDA rejected accelerated approval for Disc Medicine's bitopertin for erythropoietic protoporphyria, citing insufficient evidence that biomarker reductions translate to clinical benefit. The agency wants to see results from the ongoing Phase 3 APOLLO trial before considering traditional approval, pushing any decision to at least mid-2027. Disc Medicine plans to address FDA concerns with APOLLO data expected in Q4 2026.
Disc Medicine received a complete response letter from the FDA for bitopertin in erythropoietic protoporphyria, with the agency requesting Phase 3 APOLLO trial results before approval. The company expects to respond by mid-2027.
The FDA issued a Complete Response Letter for bitopertin in erythropoietic protoporphyria, acknowledging the drug lowers PPIX levels but requiring Phase 3 APOLLO trial results to demonstrate clinical benefit before approval.
Disc Medicine received a complete response letter from the FDA for bitopertin as a treatment for erythropoietic protoporphyria. The FDA acknowledged the drug lowers PPIX levels but requires evidence from the ongoing Phase 3 APOLLO study before approval.
