Jivi (damoctocog alfa pegol) / Bayer - LARVOL DELTA

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

Effectiveness and safety of damoctocog alfa pegol in patients with hemophilia A by body mass index (ISTH 2025) - P | "One treatment-emergent adverse event led to discontinuation (tendonitis). Table or Figure Upload"

Clinical • Cardiovascular • Genetic Disorders • Hematological Disorders • Hemophilia • Hemophilia A • Hypertension • Obesity • Rare Diseases

HEM-POWR interim analysis of damoctocog alfa pegol in patients with hemophilia A in Canada (ISTH 2025) - P | "No discontinuations, inhibitors, nor deaths were reported. Table or Figure Upload"

Clinical • Hematological Disorders • Hemophilia • Hemophilia A • 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

Effectiveness and safety of damoctocog alfa pegol extended dosing regimens in hemophilia A (ISTH 2025) - P | "No study drug-related TEAEs, TEAEs of special interest, or new inhibitors were reported in either group. Table or Figure Upload"

Clinical • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Damoctocog alfa pegol in patients aged 7 to <12 years of age; an interim analysis of the Alfa-PROTECT extension (ISTH 2025) - P3 | "The median (range) annual utilization was 5808 (4352–7251) IU/kg/year. Table or Figure Upload"

Clinical • Hematological Disorders • Hemophilia • Hemophilia A • Pain • Rare Diseases

Impact of Extended Half-Life Factor VIII on Pharmacokinetics and Bleeding Rates in Hemophilia A (ISTH 2025) - "Patients initially treated with SHL FVIII (Beriate®, Immunate®, Octanate®, Advate®, Novoeight®, Hemophil M®, Xyntha®) and later switched to EHL FVIII (Adynovate®, Jivi®) were included. A weak, non-significant negative correlation existed between spontaneous bleeding and T1/2 for both SHL (r=-0.23, IC 95% -0.51 to 0.09, p>0.05) and EHL (r=-0.24, IC 95% -0.49 to 0.05, p>0.05). A significant positive correlation was observed between AUC and T1/2 (r=0.79, IC 95% 0.7 to 0.86, p<0.05) Table or Figure Upload"

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

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

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

Role of factor VIII as a regulator of angiogenesis and promoter of endothelial barrier stability (ISTH 2025) - "HA BOECs were treated in vitro with simoctocog alfa, efmoroctocog alfa, rurioctocog alfa pegol, damoctocog alfa pegol, octocog alfa, efanesoctocog alfa or non-factor therapy, emicizumab. Furthermore, simoctocog alfa in vivo rescue was greater compared to efmoroctocog alfa or efanesoctocog alfa. These effects on ECs may be mediated by the binding and signaling of simoctocog alfa to the ECs surface."

Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

LIFE-ACTIVE: Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study) (clinicaltrials.gov) - P=N/A | N=10 | Completed | Sponsor: Bayer | Active, not recruiting ➔ Completed | Trial completion date: Jun 2027 ➔ Jul 2024

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

U.S. FDA Grants Approval for Jivi Antihemophilic Factor (Recombinant), PEGylated-aucl in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia A (Congenital Factor VIII Deficiency) (Businesswire) - "Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients 7 years of age and older with hemophilia A (congenital Factor VIII deficiency)...The approval is based on data from the Alfa-PROTECT and PROTECT Kids studies, demonstrating Jivi’s safety and efficacy in children aged 7 to under 12 years with severe hemophilia A."

FDA approval • Hemophilia A

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2025 (European Medicines Agency) - "On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Jivi. The marketing authorisation holder for this medicinal product is Bayer AG....Treatment and prophylaxis of bleeding in previously treated patients ≥ 7 years of age with haemophilia A (congenital factor VIII deficiency)."

CHMP • Hemophilia A

Bayer Pharmaceutical Gets CDSCO Panel Nod To Import, Market Recombinant Factor VIII (Medical Dialogues) - "Bayer Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the product Antihemophilic Factor (Recombinant Factor VIII) PEGylatedaucl 500 IU/1000 IU/2000 IU/3000 IU (Damoctocog Alfa Pegol) with the condition to conduct a Phase-IV study in India....Accordingly, the expert panel suggested that the firm should submit a Phase-IV study protocol within 3 months of import and marketing permission."

Approval • Clinical protocol • Hemophilia • Hemophilia A

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

Fifth interim analysis of the HEM-POWR study: A post hoc analysis of real-world effectiveness of damoctocog alfa pegol in patients with severe and nonsevere haemophilia A (EAHAD 2025) - No abstract available

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

LIFE-ACTIVE: Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study) (clinicaltrials.gov) - P=N/A | N=10 | Active, not recruiting | Sponsor: Bayer | Trial primary completion date: Dec 2026 ➔ May 2024

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

Safety profile of damoctocog alfa pegol: Fifth interim analysis of the real-world HEM-POWR study for previously treated patients with severe and nonsevere haemophilia A (EAHAD 2025) - No abstract available

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

Year 3 interim results from HA-SAFE: an observational study evaluating long-term safety of treatment with damoctocog alfa pegol (EAHAD 2025) - No abstract available

Clinical • Observational data

Effectiveness and safety of damoctocog alfa pegol in the fifth interim analysis of the HEM-POWR study: A post hoc analysis of patients with severe and nonsevere haemophilia A from Nordic study sites (EAHAD 2025) - No abstract available

Clinical • Retrospective data • 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

Role of Factor VIII As a Regulator of Angiogenesis and Promoter of Endothelial Barrier Stability (ASH 2024) - "HA BOECs were treated in vitro with the rFVIII products simoctocog alfa (Nuwiq®), efmoroctocog alfa (Elocta®), rurioctocog alfa pegol (Adynovate®), damoctocog alfa pegol (Jivi®), octocog alfa (Advate®), or emicizumab (Hemlibra®). Investigating the potential extra-coagulative role of FVIII could be crucial to understanding the key molecular targets at the cellular level which impair EC function in patients with HA. Knowledge of the possible effect of different rFVIII products and non-factor therapies on EC function can be used to optimize therapeutic approaches, which in turn may result in safer and more efficient treatment of HA."

Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Hemophilia • Hemophilia A • Osteoarthritis • Rare Diseases

Fourth Interim Analysis of the Hem Powr Study: A Post Hoc Analysis of Real-World Effectiveness and Safety of Damoctocog Alfa Pegol in Adolescent and Older Patients with Hemophilia a (ASH 2024) - P | "These findings can inform routine clinical use of damoctocog alfa pegol in adolescent and older patients. Funded by Bayer."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • Cardiovascular • Cerebral Hemorrhage • Epilepsy • Hematological Disorders • Hemophilia • Hemophilia A • Hypertension • Rare Diseases

Real-World Data on Hemophilia a Patient Usage of Bay 81-8973 and Bay 94-9027 Stratified By Body Mass Index Categories in the Athndataset (ASH 2024) - "Overall, a low number of bleeds were recorded in all BMI categories; however, the underweight and healthy weight patients numerically had the highest ABRs of all, using the highest amount of IU/kg but a smaller percentage infusing at the same frequency than the overweight and obese patients. Knowing that in vivo recovery with Factor VIII tends to be lowest in underweight patients, these data support previous findings that not only patients with high but also those with low BMIs should potentially be dosed according to different body measurements.These data should be interpreted with caution owing to limitations of real-world studies."

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