USFDAJun 9, 2026, 08:31 AM
Disc Medicine aligns with FDA on bitopertin Phase 3 for EPP approval
AI Summary
Disc Medicine completed a Type A meeting with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) for its New Drug Application (NDA) for bitopertin in erythropoietic protoporphyria (EPP). The company aligned with the FDA that the ongoing Phase 3 APOLLO study, if successful, can serve as the basis for a response to the CRL and could potentially support a traditional approval. Data from the APOLLO study is expected in Q4 2026, with a CRL response submission by the end of 2026 and an FDA decision anticipated by mid-2027.
Key Highlights
- Completed Type A meeting with FDA on bitopertin NDA for EPP.
- FDA aligned that successful Phase 3 APOLLO study can support CRL response.
- APOLLO study results could potentially lead to traditional approval.
- APOLLO is a double-blind, placebo-controlled Phase 3 study for patients aged 12 and above.
- Co-primary endpoints include sunlight tolerance and whole blood metal-free PPIX change.
- APOLLO study data expected in Q4 2026.
- CRL response submission planned by end of 2026.
- FDA decision on bitopertin anticipated by mid-2027.
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