Posted by Michael Wonder on 13 Feb 2026
Disc Medicine receives complete response letter from FDA for bitopertin for the treatment of EPP
13 February 2026 - Disc Medicine announced that the US FDA today issued a complete response letter for the new drug application for bitopertin as a treatment for patients with erythropoietic protoporphyria.
Bitopertin has been under review for accelerated approval and as part of the Commissioner’s National Priority Voucher pilot program.
