---
title: "FibroGen: FDA Grants Orphan Drug Designation To Roxadustat For MDS"
description: "FibroGen, Inc. announced that the FDA granted Orphan Drug Designation to roxadustat for treating myelodysplastic syndromes. Roxadustat showed improved transfusion-independence in patients with high tr"
type: "news"
locale: "en"
url: "https://longbridge.com/en/news/269719440.md"
published_at: "2025-12-15T12:38:45.000Z"
---

# FibroGen: FDA Grants Orphan Drug Designation To Roxadustat For MDS

> FibroGen, Inc. announced that the FDA granted Orphan Drug Designation to roxadustat for treating myelodysplastic syndromes. Roxadustat showed improved transfusion-independence in patients with high transfusion burden in a Phase 3 trial. The company plans to submit the Phase 3 protocol to the FDA by Q4 2025. Roxadustat is already approved for anemia treatment in Europe, Japan, and other countries.

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FibroGen, Inc. (FGEN) announced that the Office of Orphan Products Development of the  
FDA has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes. The company said Roxadustat showed an improvement in transfusion-independence in a subset of patients with high transfusion burden in a post-hoc analysis from the Phase 3 MATTHERHORN trial. The company is finalizing the Phase 3 protocol in the patient population for submission to the FDA in the fourth quarter of 2025.

Roxadustat is approved in Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis and not on dialysis.

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> **Disclaimer**: This article is for reference only and does not constitute any investment advice.