FDA Grants Orphan Drug Designation to FibroGen's Roxadustat for Myelodysplastic Syndromes

Reuters2025-12-15

FDA Grants Orphan Drug Designation to FibroGen's Roxadustat for Myelodysplastic Syndromes

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. FibroGen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9601989-en) on December 15, 2025, and is solely responsible for the information contained therein.

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