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# Fibrogen Misses Endpoint in Roxadustat Anemia Trial
- URL: https://www.fdaweb.com/fibrogen-misses-endpoint-in-roxadustat-anemia-trial/
- Published: 2023-05-05T12:00:00.000Z
- Updated: 2026-09-14T18:29:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154382

FibroGen says a Phase 3 study of its anemia drug roxadustat did not meet its primary efficacy endpoint. The MATTERHORN study involving roxadustat for treating anemia in 140 patients with transfusion-dependent lower risk myelodysplastic syndromes showed the proportion of patients who achieved red blood cell transfusion independence in the first 28 weeks was 47.5% for the roxadustat arm compared to 33.3% for placebo, the company says. The drug’s adverse event profile was “generally consistent with previous findings,” it adds.

In 2021, FDA issued a complete response letter seeking more clinical study data for a FibroGen NDA for roxadustat to treat anemia due to chronic kidney disease. That followed a 13-1 vote by the agency’s Cardiovascular and Renal Drugs Advisory Committee that recommended against the NDA’s approval. Committee members agreed with an FDA [briefing document](https://www.fda.gov/media/150728/download?ref=fdaweb.com) citing risks of serious thromboembolic events, as well as other risks ([see earlier story](https://www.fdaweb.com/fda-raises-roxadustat-safety-concerns/)).

Roxadustat is described as the first HIF-PH inhibitor, a new class of medicines that promotes erythropoiesis through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Fibrogen says the drug is approved in China, Europe, Japan, and numerous other countries for treating anemia in adult patients with chronic kidney disease.