Disc Medicine Gains FDA Agreement to Use Phase 3 APOLLO Data as CRL Response by Q4 2026
IRON•Disc Medicine and FDA agreed that positive results from the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria can form the basis for the Complete Response Letter submission. Data are expected in Q4 2026 with a CRL response filing by year-end 2026 and a potential FDA decision by mid-2027.
1. FDA Meeting Outcomes
Disc Medicine completed a Type A meeting with the FDA to discuss the Complete Response Letter for bitopertin’s NDA in erythropoietic protoporphyria, securing agreement that positive results from the Phase 3 APOLLO study can constitute the official CRL response and may support a traditional approval pathway.
2. APOLLO Study Design
APOLLO is a double-blind, placebo-controlled Phase 3 trial enrolling patients aged 12 and above with EPP and X-linked protoporphyria across the US, Canada, Europe and Australia. Co-primary endpoints are average monthly sunlight time without pain during the sixth month and percent change in whole blood metal-free PPIX after six months.
3. Next Steps and Timeline
Disc Medicine aims to report APOLLO data in Q4 2026, submit its CRL response by the end of 2026 and anticipate an FDA decision by mid-2027, advancing bitopertin toward potential traditional approval.
4. Bitopertin Development Background
Bitopertin is an oral GlyT1 inhibitor designed to modulate heme biosynthesis and address hematologic diseases. Disc obtained global rights from Roche in May 2021 and has evaluated bitopertin through multiple Phase 2 and Phase 3 trials in erythropoietic porphyrias.
