SILVER SPRING
Bitopertin CRL issued for EPP
- Sponsor
- Disc Medicine, Inc. $IRON
- Drug
- bitopertin
- Indication
- erythropoietic protoporphyria
FDA issued a Complete Response Letter to Disc Medicine for bitopertin in erythropoietic protoporphyria.
What this means
Bitopertin is an experimental drug that blocks glycine absorption, aiming to treat erythropoietic protoporphyria (EPP), a rare disorder causing severe light sensitivity. The FDA declined to approve bitopertin, requesting more data from Disc Medicine before reconsideration. This delay means EPP patients won’t gain access to this potential treatment until the company addresses the agency’s concerns, leaving sunlight avoidance as the primary management strategy.