News Related to X-linked Protoporphyria

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Disc Medicine Receives FDA Complete Response Letter for Bitopertin EPP Treatment

Feb 14, 2026

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.

FDA Denies Accelerated Approval for Bitopertin in EPP, Awaits Phase 3 Trial Results

Feb 14, 2026

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.