Disc Medicine Opens Expanded Access Program for Bitopertin Ahead of Q4 2026 Data
IRON•Disc Medicine launched an expanded access program granting U.S. patients with erythropoietic protoporphyria and X-linked protoporphyria early access to bitopertin. Phase 3 APOLLO trial topline data remain slated for Q4 2026, with a potential FDA decision by mid-2027.
1. Launch of Expanded Access Program
Disc Medicine initiated an expanded access program in the U.S. allowing patients aged 12 and older with erythropoietic protoporphyria and X-linked protoporphyria who lack satisfactory therapies to receive investigational bitopertin prior to regulatory approval.
2. Ongoing Phase 3 APOLLO Trial
Bitopertin is being evaluated in the double-blind, placebo-controlled Phase 3 APOLLO study, with topline results expected in Q4 2026; data from this trial will form the basis of the company’s regulatory submission.
3. Regulatory Outlook and Next Steps
Disc holds global rights to bitopertin under a Roche license and anticipates submitting any complete response letter in late 2026, targeting a potential FDA approval decision by mid-2027 while leveraging EAP patient feedback.
