AstraZeneca Announces FDA Approval of Roxadustat for Anemia in Myelodysplastic Syndrome

AstraZeneca today announced that the FDA has approved Evrenzo (roxadustat) for the treatment of anemia in adults with myelodysplastic syndrome (MDS) with very low to intermediate risk. In the Phase 3 MATTERHORN trial, roxadustat demonstrated a statistically significant improvement in hemoglobin response rate compared to placebo. The hemoglobin response rate was 38.5% for roxadustat versus 10.6% for placebo. Roxadustat is an oral HIF-PHI that stimulates erythropoiesis by mimicking the body's natural response to low oxygen levels. This approval provides patients with low-risk MDS a new oral treatment option for anemia.