Esperoct (antihemophilic factor (recombinant), glycopegylated-exei) / Novo Nordisk - LARVOL DELTA

Turoctocog alfa pegol versus recombinant factor VIII-Fc fusion protein: a head-to-head pharmacokinetics comparison. (PubMed, Blood Transfus) - No abstract available

Head-to-Head • Journal • PK/PD data

Advantages of FVIII-Extended Half-Life (Turoctocog Alfa Pegol) in the Management of Cardiac Surgery in a Patient with Mild Hemophilia A: A Case Report and Literature Review. (PubMed, Hematol Rep) - " This case illustrates the potential role of EHL FVIII in safely managing hemophilic patients undergoing major cardiac surgery. Given the lack of existing reports in the literature, further studies are warranted to evaluate the efficacy and safety of EHL FVIII in this setting and to potentially optimize perioperative care protocols for this patient population."

Journal • Cardiovascular • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

The efficacy, safety, and pharmacokinetics of N8-GP in previously treated Chinese patients with haemophilia A: results from the phase 3b pathfinder10 study. (PubMed, Blood Coagul Fibrinolysis) - P3 | "N8-GP appeared safe and efficacious in previously treated Chinese patients with severe HA."

Journal • P3 data • PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

'VALVE IN VALVE' IN A PATIENT WITH HEMOPHILIA A: CASE REPORT (EHA 2025) - "Improvements in prophylaxis and treatment have increased the life expectancy and quality of life of PWHs, bringing them closer to the general population in high-income countries. This patient is not anticoagulated (NV-AF, CHADS2) because he has a chronic liver disease with history of Mallory-Weiss Syndrome. Procedures such as TAVI can be performed safely in our patients, with adequate hemostatic coverage."

Case report • Clinical • Atrial Fibrillation • Cardiovascular • Heart Failure • Hematological Malignancies • Hemophilia • Hemophilia A • Hepatology • Multiple Myeloma • Oncology • Rare Diseases • Rheumatology

CHATGPT4O® AND WEEKLY PROPHYLAXIS WITH FVIIIC: WHAT CAN IT CONTRIBUTE? (EHA 2025) - "Within the VIII factors of extended half-life, Esperoct® and JIvi® include in their technical data sheets the weekly prophylaxis at different doses (75 IU/Kg and 60 IU/Kg, respectively). These FVIIICs have demonstrated efficacy and safety in clinical trials. Altuvoct® is a revolution and inaugurates a new class of CFVIII, decoupling its half-life from that of VWF. All in all, personalization of hemophilia treatment is a key aspect as well as economic management."

Hematological Disorders • Hemophilia • Rare Diseases

Use of FVIII- Extended half-life (EHL) in Major Orthopedic Surgery: Real-World Experience (ISTH 2025) - "In 64% of the procedures, Damoctocog Alfa Pegol was used, followed by Rurioctocog Alfa Pegol (18%) and Turoctocog Alfa Pegol (18%). Bleeding complications occurred in only one case (bilateral hip replacement) associated with a periprocedural complication. Table or Figure Upload"

Clinical • Real-world • Real-world evidence • Surgery • Hematological Disorders • Hemophilia • Hemophilia A • Orthopedics • Rare Diseases

Valve-in-Valve in Hemophilia (ISTH 2025) - "Pre-surgery: we administered bolus of Esperoct of 2750 IU and 30 minutes later, IV heparin bolus of 5000 IU (reversed at the end). At 24 hours, F8:C was 72% (administered 2500 IU Esperoct). At 48 hours, F8:C levels were 66%, maintaining this regimen until wound he Table or Figure Upload"

Cardiovascular • Heart Failure • Hematological Disorders • Hemophilia • Hepatology • Rare Diseases

Fc-fusion protein and glycopegylated-rFVIII pharmacokinetic comparison: a case series. (ISTH 2025) - "In detail, prophylaxis treatment with turoctocog alfa pegol allowed patients to spent 89.58% of the week with FVIII above 5% (3.27 days; IQR 0.51), while patients treated with efmoroctocog alfa spent 70.77% of time above 5% (2.48 days; IQR 0.98). Table or Figure Upload"

Clinical • PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases • Rheumatology

Balancing the thrombotic and haemorrhagic risk of non severe haemophilia A in major surgery (ISTH 2025) - "The patient received rurioctocog-alfa-pegol preoperatively (Table 1)...The patient underwent adjuvant chemotherapy with capecitabine...We performed perioperative prophylaxis with turoctocog-alfa-pegol (Table 2)...Case 2:The postoperative course was complicated by bleeding from the surgical site on day 3, requiring a single packed red blood cell transfusion, with subsequent clinical recovery. Table or Figure Upload"

Surgery • Anemia • Atherosclerosis • Cardiovascular • Dyslipidemia • Genetic Disorders • Hematological Disorders • Hemophilia • Hemophilia A • Hepatitis C • Infectious Disease • Metabolic Disorders • Nephrology • Obesity • Oncology • Pulmonary Arterial Hypertension • Rare Diseases • Renal Disease

Advancing Hemophilia A Management with the Portability of Turoctocog Alfa Pegol (N8-GP) (ISTH 2025) - "Results Six patients (mean age: 33.7 years, range 27–43) included three with moderate and three with severe hemophilia A. Before switching to N8-GP, half were treated with rurioctocog alfa pegol, while the rest used damoctocog alfa pegol, moroctocog alfa, or plasma-derived FVIII equally. The results of the satisfaction survey are presented in Figures 1 and 2. Table or Figure Upload"

Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases • Rheumatology

FVIII Half-Life Products: a Real-World Experience (ISTH 2025) - "Data on patient characteristics, treatment regimens, and pharmacokinetic profiles using WAPPS-Hemo (fig.1) , annual ABR and AJBR (table 1) were analyzed Results Among the FVIII products used, octocog alfa, efmoroctocog alfa, and damoctocog alfa showed median half-lives of 11.25 [10.75–12.25], 16.50 [13.75–17.75], and 15.38 [13.38–18.63] hours, respectively.Turoctocog alfa pegol exhibited the longest half-life at 19.75 [16.00–24.50] hours, enabling reduced infusion frequency. Bleeding control among the different FVIII-EHL was comparable. Table or Figure Upload"

Clinical • Real-world • Real-world evidence • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Coronary artery bypass graft and atrial fibrillation in a moderate hemophilia A patient (ISTH 2025) - "Indeed, he was treated on demand until 2019, when he started tertiary prophylaxis with a standard half-life FVIII, then switched to the extended half-life (EHL) turoctocog alfa pegol. Due to episodes of AF, on post-op day 7 clopidogrel and enoxaparin were discontinued, and dabigatran 110 mg twice daily was started, continuing aspirin. FVIII replacement was closely monitored, maintaining levels >50%, then gradually tapered to a prophylaxis regimen (35IU/Kg every 3 days) at discharge on day 30, maintaining trough levels 20-30%."

Clinical • Atrial Fibrillation • Cardiovascular • Diabetes • Genetic Disorders • Hematological Disorders • Hemophilia • Hemophilia A • Hypertension • Metabolic Disorders • Myocardial Infarction • Obesity • Rare Diseases • Thrombosis • Type 2 Diabetes Mellitus

Effectiveness of turoctocog alfa pegol in perioperative cardiac surgery for mild hemophilia A (ISTH 2025) - "Aims This case explores the use of FVIII-EHL (Turoctocog alfa pegol) to prevent bleeding in a patient with mild hemophilia A, providing insights into improving perioperative care. The patient participated in cardiac rehabilitation, continuing FVIII treatment and taking aspirin for three months without complications. Table or Figure Upload"

Surgery • Anesthesia • Cardiovascular • Fatigue • Hematological Disorders • Hemophilia • Hemophilia A • Pain • Rare Diseases

Use of Generative AI to analyze pegylated FVIII Concentrates (ISTH 2025) - "Methods Adynovi, Jivi and Esperoct are compared, according to data reported in EMA's technical sheets (Table 1). ChatGPT4o concludes that if the objective is to maximize cost-effectiveness efficiency under the same unit cost, Esperoct® 50 IU/Kg each 4 days is the best option followed by JIVI® at 60 IU/kg each 7 days. Table or Figure Upload"

Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Novo Nordisk A/S | Trial completion date: Feb 2025 ➔ Jun 2026 | Trial primary completion date: Feb 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Post-Marketing Surveillance (Use-results Surveillance) With Esperoct® (clinicaltrials.gov) - P=N/A | N=23 | Completed | Sponsor: Novo Nordisk A/S | Enrolling by invitation ➔ Completed | N=15 ➔ 23

Enrollment change • Trial completion • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

FVIII half-life products: A real-world experience. (PubMed, Thromb Res) - "EHL FVIII products offer significant clinical benefits, reducing the burden of frequent infusions and improving adherence while maintaining effective bleeding control. Despite these advancements, comprehensive evaluations of cost, safety, and long-term outcomes are essential to optimize their integration into haemophilia care."

Journal • Real-world evidence • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice. (PubMed, Farm Hosp) - "The pharmacokinetically guided switch from standard half-life FVIII to pegylated FVIII demonstrated significant clinical benefits with reduced bleeding rates and improvements in joint health. Additionally, improvements in pharmacokinetic parameters were observed, allowing for reduced treatment burden by decreasing administration frequency, as well as lower consumption and costs."

Journal • PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Swedish Orphan Biovitrum | Trial completion date: Apr 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Aug 2025 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Indirect Comparison of the Efficacy and Therapy-Related Costs of a Pharmacokinetic and Individualized Prophylaxis Regimen with Simoctocog Alfa Versus Other Extended-Half Life Factor VIII Concentrates (ASH 2024) - "For comparison, aggregated data was obtained from the following trials with EHL concentrates : pathfinder2 (turoctocog alfa pegol, N = 175), A-LONG (efmoroctocog alfa, N = 117), PROTECT FVIII (damoctocog alfa pegol, N = 110), PROPEL (rurioctocog alfa pegol 1–3% and 8–12%; N = 57 and 58), and XTEND-1 (efanesoctocog alfa, Group A, N = 133). Conclusion : Albeit at a generally higher weekly dose, a PK-guided, individualized prophylaxis regimen with simoctocog alfa offered comparable or significantly improved zero bleed rates and significantly lower or comparable ABRs than prophylactic regimens with EHL rFVIII concentrates. Nevertheless, the estimated annual cost of a simoctocog alfa-based regimen is 20–55% lower than with the other concentrates."

Clinical • PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Efanesoctocog Alfa versus Standard and Extended Half-Life Factor VIII Prophylaxis in Adolescent and Adult Patients with Haemophilia A without Inhibitors. (PubMed, Adv Ther) - P3 | "Efanesoctocog alfa was associated with significantly lower ABRs (any, spontaneous and joint) compared with EHL or SHL prophylaxis therapies. Patients had, on average, 2.2 and 3.6 fewer bleeds per year versus EHL and SHL therapies, respectively."

Journal • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in the therapy of hemophilia A in clinical practice. (PubMed, Farm Hosp) - "The pharmacokinetically guided switch from standard half-life FVIII to pegylated FVIII demonstrated significant clinical benefits with reduced bleeding rates and improvements in joint health. Additionally, improvements in pharmacokinetic parameters were observed, allowing for reduced treatment burden by decreasing administration frequency, as well as lower consumption and costs."

Journal • PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Real-world insights into the management of hemophilia A in Italy: treatment patterns and healthcare resource utilization. (PubMed, Blood Res) - "These findings revealed an extensive use of EHL FVIII products, suggesting growing efforts from clinicians to optimize prophylactic strategies and achieve better bleeding protection."

HEOR • Journal • Real-world • Real-world evidence • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Swedish Orphan Biovitrum

New P1 trial • Hematological Disorders • Hemophilia • Rare Diseases

Evaluation of plasmin generation in severe haemophilia A patients treated with novel therapies (ISTH 2024) - "Aims: To evaluate PG kinetics pre and post treatment with an extended half-life recombinant factor VIII concentrate (rFVIII-EHL) and factor VIII (FVIII) bispecific antibody (FVIII-bsAb) in SHA A calibrated plasmin generation assay (PGA) was performed on samples from healthy volunteers (n=35), SHA patients treated with rFVIII-EHL, turoctocog alfa pegol (n=19) and SHA patients treated with FVIII-bsAb, emicizumab (n=19), after informed consent and ethics approval. There were no statistical differences in core PG parameters (EPP, peak and velocity) between HV and pre-treatment SHA (FVIII ≤5 IU/dL) samples (Table 1). A significant weak correlation (r=0.348, p=0.040) was seen in HV between EPP and FVIII levels (FVIII:62-220 IU/dL). Interestingly, no correlation (r= 0.052, p=0.831) was observed between EPP and FVIII levels (FVIII:97-171 IU/dL) in post-EHL rFVIII treatment samples."

Clinical • Hematological Disorders • Hemophilia • Rare Diseases