India, June 9 -- Disc Medicine, Inc. (IRON) announced it has completed a Type A meeting with the U.S. FDA regarding the CRL for its NDA of bitopertin in erythropoietic protoporphyria (EPP). The company confirmed alignment with the FDA that the ongoing Phase 3 APOLLO study, if successful, can serve as the basis for a CRL response and potentially support a traditional approval.
The APOLLO trial is a double-blind, placebo-controlled Phase 3 study enrolling patients aged 12 and above with EPP and X-linked protoporphyria (XLP) across sites in the U.S., Canada, Europe, and Australia. Its co-primary endpoints measure average monthly time in sunlight without pain during the last month of the six-month treatment period, and percent change from base...