News Related to Ferrochelatase

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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.

FDA Rejects Disc Medicine's Bitopertin for Rare Blood Disorder Under Fast-Track Program

Feb 14, 2026

The FDA declined to approve Disc Medicine's bitopertin for erythropoietic protoporphyria on February 13, 2026, citing insufficient evidence linking biomarker reductions to clinical benefit. The company will pursue traditional approval using Phase 3 APOLLO trial data expected in Q4 2026.