BioPharma Dive· Delilah Alvarado·· 3 hours agoPickScore82
Disc’s once-spurned rare disease drug to get a second chance at approval
In brief
Disc Medicine announced Monday that bitopertin met all primary and secondary endpoints in a Phase 3 trial in erythropoietic protoporphyria (EPP), and plans to resubmit its marketing application to the FDA by year-end, with potential approval as early as 2027.
Why it matters
Phase 3 data linking PPIX reduction to improved light tolerance address the prior complete response letter's surrogate endpoint concerns and support resubmission.
Source: BioPharma Dive · biopharmadive.com