Epotrex-NP (epoetin alfa biosimilar) / Novell Pharma - LARVOL DELTA

A Phase 1b/2 Study of the Efficacy and Safety of Combination Hydroxyurea and Dose-Escalated Erythropoietin for Treatment of Anemia in Sickle Cell Disease (ACHiEvE-SCD) (ASH 2024) - P1/2 | "Here, we present the preliminary results of a Phase 1b/2 multicenter, open-label, dose escalation study of epoetin alfa (EPO) for the treatment of anemia in patients (pts) with SCD on HU...Inclusion criteria included age ≥ 18 years, diagnosis of SCD (HbSS or HbS/β0-thalassemia), screening Hb ≤ 9.0 g/dL, on stable-dose HU, and no recent transfusions, voxelotor or ESA treatment...Nearly all participants experienced a Hb response with a relatively low-to-moderate dose of EPO. Subsequent analyses will evaluate the effect of EPO therapy on transfusion burden and other clinical outcomes."

Clinical • P1/2 data • Anemia • Cardiovascular • Chronic Kidney Disease • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Hypertension • Myelodysplastic Syndrome • Nephrology • Oncology • Renal Disease • Sickle Cell Disease • Thrombosis