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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05020184 |
Effect of Oral Cimetidine in the Protoporphyrias |
COMPLETED | PHASE2 |
| NCT02979249 |
Oral Iron for Erythropoietic Protoporphyrias |
COMPLETED | NA |
| NCT01688895 |
Erythropoietic Protoporphyrias: Studies of the Natural History, Genotype-Phenotype Correlations, and Psychosocial Impact |
COMPLETED |
