FibroGen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its drug roxadustat for the treatment of myelodysplastic syndromes (MDS). This designation is intended for drugs that treat rare diseases affecting fewer than 200,000 people in the U.S. and provides benefits such as FDA fee exemptions, financial incentives for clinical development, and seven years of market exclusivity upon approval. Roxadustat showed promising results in improving transfusion-independence for MDS patients with high transfusion burden in a post-hoc analysis from the Phase 3 MATTERHORN trial. FibroGen plans to submit the Phase 3 protocol for this patient population to the FDA in the fourth quarter of 2025.