FibroGen Inc. $(FGEN)$ has announced positive feedback from a Type C meeting with the FDA, paving the way for the advancement of its drug, roxadustat, in treating anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell transfusion burden. This follows a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial, which demonstrated a significant treatment effect. The company is preparing for a pivotal Phase 3 trial, with plans to submit the full protocol to the FDA by the fourth quarter of 2025. This regulatory progress highlights roxadustat's potential as an important addition to treatment options for patients with significant unmet needs.
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