FDA issues Complete Response Letter for Disc Medicine’s bitopertin
The FDA issued a Complete Response Letter for Disc Medicine’s bitopertin NDA in EPP, saying additional evidence is needed. The agency wants Phase 3 APOLLO data before deciding.
whole blood metal-free PPIX
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FDA Denies Accelerated Approval for Bitopertin in EPP, Awaits Phase 3 Trial Results
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.
FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in EPP Treatment
The FDA issued a Complete Response Letter for Disc Medicine's bitopertin New Drug Application for erythropoietic protoporphyria, requiring results from the ongoing Phase 3 APOLLO study before making an approval decision. Topline data is expected in Q4 2026.
Disc Medicine Receives FDA Complete Response Letter for Bitopertin EPP Treatment
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.