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Investing.com -- FibroGen Inc (NASDAQ:FGEN) stock jumped 9.9% following positive feedback from the U.S. Food and Drug Administration supporting the advancement of roxadustat for treating anemia in patients with low-risk myelodysplastic syndromes (LR-MDS) who have high red blood cell transfusion burden.
The FDA’s favorable response came after a Type C meeting where the company presented post-hoc analysis data from its MATTERHORN Phase 3 trial. The analysis showed that among patients with high transfusion burden, 36% of those receiving roxadustat achieved transfusion independence for 56 days or more, compared to just 7% in the placebo group.
"We are very pleased with the feedback we received from the FDA regarding roxadustat in patients with LR-MDS and anemia with high transfusion burden. This indication, despite recent approvals, still represents a patient population with significant unmet need," said Thane Wettig, Chief Executive Officer of FibroGen.
The company plans to conduct a new Phase 3 trial involving approximately 200 patients with LR-MDS who require four or more packed red blood cell units in two consecutive 8-week periods prior to randomization. These patients must be refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents therapy.
FibroGen highlighted that roxadustat’s oral administration route could provide advantages over injectable alternatives currently available for this patient population. The company intends to submit the full Phase 3 protocol to the FDA in the fourth quarter of 2025.
The planned study’s principal investigator, Dr. Amer Zeidan of Yale School of Medicine, noted that despite recent approvals of injectable drugs for this indication, "there is a significant unmet need for novel, effective oral agents for this patient population."
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