Epogen (epoetin alfa) / Amgen - LARVOL DELTA

Overall survival (OS) and duration of response for transfusion independence (TI) in erythropoiesis stimulating agent (ESA)–naive patients (pts) with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS) treated with luspatercept (LUSPA) vs epoetin alfa (EA) in the COMMANDS trial. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT03682536 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Efficacy of Treating Anemia of Prematurity with Erythropoietin Stimulating Agents (ESAs) in Very Low Birth Weight Infants (PAS 2025) - "Packed Red Blood Cell (PRBC) transfusions and erythropoiesis stimulating agents (ESAs) such as Epoetin alfa (EPO) are used to increase Hb and Hct levels... The model shows that duration of respiratory support and % phlebotomy loss are factors that decrease EPO efficacy in VLBW patients. These variables are highly correlated with birth weight. When looking at birth weight only, smaller babies are more than twice as likely to receive additional transfusions after EPO."

Clinical • Prematurity • Anemia • Bronchopulmonary Dysplasia • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Retinal Disorders • Retinopathy of Prematurity

ACHiEvE-SCD: Hydroxyurea and EPO in Sickle Cell Disease (clinicaltrials.gov) - P1/2 | N=17 | Completed | Sponsor: Julia Xu | Active, not recruiting ➔ Completed

Trial completion • Anemia • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Randomized Trial of Pegmolesatide for the Treatment of Anemia in Patients With Nondialysis CKD. (PubMed, Kidney Int Rep) - P3 | "No drug-related hypersensitivity reactions or fatal events were observed. Pegmolesatide demonstrated comparable efficacy to epoetin alfa in elevating and maintaining Hb levels in patients with NDD-CKD with anemia without new safety concerns (ClinicalTrials.gov identifier: NCT03903809)."

Journal • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Hypertension • Immunology • Nephrology • Renal Disease

Trends In Oral JAK Inhibitor And Other Drug Use For Myelofibrosis: A Retrospective Real-World Study (ISPOR 2025) - "Ruxolitinib (RUX) and hydroxyurea (HU) were the most common MF-related drug treatments...Among the erythropoiesis-stimulating agents, epoetin alfa was the most used, with a reduction seen in both countries (Argentina: 81.8% in 2010 vs. 26.0% in 2022; Brazil: 58.1% in 2015 vs. 52.6% in 2022). RUX and HU were the most commonly used drugs to treat MF in Argentina and Brazil but followed different usage trends. RUX and HU were the most commonly used drugs to treat MF in Argentina and Brazil but followed different usage trends. Most patients are still receiving treatment with HU in Argentina, whereas HU is now less commonly prescribed in Brazil. As alternative JAKis addressing all manifestations of MF become available, a shift in initial treatment options favoring those agents is expected."

Real-world • Real-world evidence • Retrospective data • Hematological Disorders • Myelofibrosis

Pharmacological Countermeasures for High Altitude (clinicaltrials.gov) - P4 | N=18 | Active, not recruiting | Sponsor: United States Army Research Institute of Environmental Medicine | Trial completion date: Mar 2025 ➔ Sep 2025

Trial completion date

Exploring Anemia and the Underdiagnosis of Myelofibrosis: Findings From a Real-World Retrospective Cohort (ISPOR 2025) - "Epoetin alfa was used by 68 (56.7%) patients in HeIIM-A and 97 (52.4%) in HeIIM-B. Anemia is a highly prevalent and burdensome manifestation of MF with over half of patients with anemia receiving RBC transfusions in both Argentina and Brazil. Almost three-quarters of patients developed anemia before their MF diagnosis, highlighting anemia as an early indicator of MF, and the importance of its early detection and monitoring for timely management."

Real-world • Real-world evidence • Retrospective data • Anemia • Hematological Disorders • Myelofibrosis

EPO-PRETAR: A Trial Testing Early Vs Late Onset of EPO Alfa Treatment in Lower Risk MDS (clinicaltrials.gov) - P3 | N=124 | Active, not recruiting | Sponsor: Groupe Francophone des Myelodysplasies | Recruiting ➔ Active, not recruiting | Trial completion date: May 2024 ➔ Oct 2028

Enrollment closed • Trial completion date • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

PARVOVIRUS AND NEW-ONSET SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): A CATASTROPHIC COMBINATION (SCCM 2025) - "On hospital day 3, left upper extremity weakness developed, and MRI showed "diffuse multifocal small infarcts." Management escalated to IVIG, Rituximab, and Epogen. This diagnosis should be suspected when hemolytic anemia and thromboses are seen. Anticoagulation initiation is of utmost importance to prevent morbidity and mortality."

Anemia • Autoimmune Hemolytic Anemia • Complement-mediated Rare Disorders • Genetic Disorders • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Ophthalmology • Pain • Pediatrics • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombosis • Women's Health

Vadadustat (Vafseo) for anemia of chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

EVEREST: EVR and EPO for Liver Transplant Tolerance (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1 trial • Hepatology • Transplantation

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS (PRNewswire) - "Our established products, which consist of EPOGEN (epoetin alfa), Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide) and Neulasta (pegfilgrastim), generated $500 million of sales in the fourth quarter. Sales decreased 29% year-over-year for the fourth quarter, driven by volume declines, unfavorable changes to estimated sales deductions and lower net selling price. Sales decreased 19% for the full year, driven by volume declines, lower net selling price and unfavorable changes to estimated sales deductions."

Sales • Chronic Kidney Disease • Hematological Disorders • Neutropenia

Epoetin alfa has a potent anxiolytic effect on naive female rats. (PubMed, BMC Pharmacol Toxicol) - "The present study found beneficial effects of epoetin alfa on behaviors. Further studies on the effect of derivatives of erythropoietin hormone on anxiety-like behaviors are needed."

Journal • Preclinical • Mood Disorders • Psychiatry

A COMPARATIVE STUDY OF DESIDUSTAT AND ERYTHROPOIETIN STIMULATING AGENTS IN CKD-RELATED ANEMIA (ISN-WCN 2025) - "A total of 60 patients with CKD-related anemia were enrolled, with 30 patients receiving Desidustat and 30 receiving ESA therapy (epoetin alfa). Adverse events were minimal and comparable in both groups. Download: Download high-res image (167KB) Download: Download full-size image Conclusions Desidustat offers a comparable rise in hemoglobin levels to ESAs in CKD-related anemia, with additional benefits of reduced cost, ease of administration, and ease of storage."

Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology

PEGMOLESATIDE FOR THE TREATMENT OF ANEMIA IN NON-DIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE PATIENTS: POST-HOC ANALYSIS OF A PHASE 3 TRIAL (ISN-WCN 2025) - P3 | "Those who received pegmolesatide were more likely to have a smaller reduction in SF and TSAT over 52 weeks (Figure 2). Download: Download high-res image (284KB) Download: Download full-size image Download: Download high-res image (148KB) Download: Download full-size image Conclusions Pegmolesatide is non-inferior in increasing Hb level compared to epoetin alfa, and may optimize iron supplements and utilizations in NDD-CKD patients."

Clinical • P3 data • Retrospective data • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Blood management protocol for baseline anemic patients undergoing hip arthroplasty. (PubMed, Arch Orthop Trauma Surg) - "THA patients with baseline Hb < 12 g/dL had a zero-transfusion rate and significantly lower blood loss than those with Hb ≥ 12 g/dL. Optimizing preoperative Hb levels above 12 g/dL is not necessary for patients undergoing standard THA. Optimizing preoperative Hb may not be necessary for patients with baseline anemia due to their low blood loss. The PBM protocol was effective in conserving blood, time, and resources, offering a viable alternative for blood conservation in elective hip arthroplasty."

Journal • Retrospective data • Hematological Disorders • Orthopedics

Efficacy and safety of daprodustat in patients on peritoneal dialysis in the ASCEND-D trial. (PubMed, Nephrol Dial Transplant) - P3 | "This subgroup analysis of the ASCEND-D trial demonstrated comparable efficacy and safety of daprodustat versus darbepoetin alfa in PD patients, supporting its use in the treatment of anemia in these patients."

Journal • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Health-Related Quality of Life of Luspatercept Versus Epoetin Alfa in Red Blood Cell Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes: Results from the Final Datacut of the Phase 3 COMMANDS Study (ASH 2024) - P3 | "Conclusions : The analyses indicate superior treatment effects of luspatercept over epoetin alfa on shortening time to achieving a meaningful HRQoL improvement or delaying time to experiencing a meaningful HRQoL deterioration or RBC transfusion. These findings provide further evidence to support the use of luspatercept as a front-line treatment for patients with RBC transfusion-dependent LR-MDS."

Clinical • HEOR • P3 data • Anemia • Fatigue • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Long-Term Response Analysis of Transfusion Independence in Erythropoiesis Stimulating Agent–Naive Patients with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes Treated with Luspatercept Vs Epoetin Alfa in the COMMANDS Trial (ASH 2024) - P3 | "Progression rates to high-risk MDS and AML were low in both treatment arms. These data support luspatercept as the treatment of choice in TD ESA-naive pts with lower-risk MDS."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • SF3B1

Changes in Red Blood Cell Transfusion Burden with Luspatercept Versus Epoetin Alfa in Patients with Lower-Risk Myelodysplastic Syndromes in the Phase 3, Open-Label, Randomized, Controlled COMMANDS Trial (ASH 2024) - P3 | "Conclusions : The findings from the COMMANDS trial demonstrated that luspatercept treatment led to a decrease in RBCT burden compared with epoetin alfa in ESA-naive pts with LR-MDS, evident by the number of RBC units transfused and RBCT visits over a 1.5-year period. When analyzed by RBCT burden category, transfusion burden was also substantially lower for luspatercept compared with epoetin alfa."

Clinical • P3 data • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Clinical Benefits of Achieving Hemoglobin (Hb) Levels ≥ 10 g/dL in Transfusion-Dependent (TD) Erythropoiesis-Stimulating Agent (ESA)-Naive Patients (Pts) with Lower-Risk (LR) Myelodysplastic Syndromes (MDS) Treated with Luspatercept in the COMMANDS Trial (ASH 2024) - P3 | "Luspatercept demonstrated superior response vs epoetin alfa in RBC TI with concurrent mean Hb increase ≥1.5 g/dL in weeks 1-24 (60.4% vs 34.8%, P < 0.0001; Della Porta MG, et al. Luspatercept dose escalation maintained target Hb levels without significantly increasing incidence or severity of TEAEs. Pts with lower Hb levels at baseline showed a trend requiring higher dose, supporting the clinical benefit of luspatercept dose escalation in pts with LR-MDS."

Clinical • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Combining ESA and Luspatercept in Non-RS MDS Patients Having Failed ESA - Results of the Phase 1-2 Part a of the GFM Combola Study (ASH 2024) - "Based on a TITE-BOIN-ET design, Epoetin alfa was administered weekly at dose concentrations ranging from 30 000UI to 60 000 UI...All patients had resistance to ESA and 7 had also received Revlimid (n=3), IDH inhibitors (n=2), Thalidomide (n=1), AZA (n=1)...Based on the results of this Phase 1 study, the dosing schedule Luspatercept 1.75 mg/kg/21d and EPO 60 000 UI/w, that balanced clinical efficacy and safety profile was selected as the RP2D. This regimen is being compared to Luspatercept 1.75 mg/kg/21d in the ongoing randomized Phase 2 study."

Clinical • P1/2 data • Anemia • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Myelodysplastic Syndrome

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 • Pain • Renal Disease • Sickle Cell Disease • Thrombosis

VOICE: Vafseo Outcomes In-Center Experience (clinicaltrials.gov) - P3 | N=2200 | Recruiting | Sponsor: USRC Kidney Research | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Acute Kidney Injury after Cardiac Surgery Is Associated with Increased Iron Deficiency Anemia Risk (ASH 2024) - "Exclusion criteria included diagnoses of acute kidney failure (ICD-10-CM N17), chronic kidney disease (N18), end stage renal disease (N18.6), renal dialysis (Z99.2), and hemoglobin ≤8 g/dL within 1-month preoperatively.A propensity-matched cohort analysis was used to examine the relationship between 7-day postoperative AKI and 3-month, 6-month, and 12-month postoperative mortality, all cause anemia, iron deficiency anemia (D50), repeat cardiac surgery, RBC transfusion, acute myocardial infarction (MI) (I21), atrial fibrillation and flutter (I48), and recent hemoglobin (Hb) and hematocrit (Hct) levels within the outcome period.Propensity score matching was performed for age, ethnicity, race, sex, preoperative diabetes mellitus (E08-E13), neoplasms (C00-D49), alcohol related disorders (F10), liver diseases (K70-K77), sepsis (A40-41), MI, cerebral infarction (I63), essential hypertension (I10), renal tubulo-interstitial diseases (N10-N16), acute and subacute endocarditis..."

Surgery • Acute Kidney Injury • Anemia • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Diabetes • Diabetic Nephropathy • Hematological Disorders • Hepatology • Hypertension • Infectious Disease • Metabolic Disorders • Myocardial Infarction • Nephrology • Oncology • Renal Disease • Septic Shock