Jivi (damoctocog alfa pegol) / Bayer - LARVOL DELTA

Evaluating Costs and Efficacy of rFVIII Prophylaxis Using Matching-Adjusted Indirect Comparisons in Hemophilia A. (PubMed, TH Open) - "Methods Matching-adjusted indirect comparisons (MAICs) were performed to compare simoctocog alfa with efanesoctocog alfa (ALTUVIIIO) and turoctocog alfa pegol (Esperoct), and results were integrated with a previously published MAIC comparing simoctocog alfa with efmoroctocog alfa (ELOCTATE), damoctocog alfa pegol (JIVI), and rurioctocog alfa pegol (ADYNOVATE). In comparison with efanesoctocog alfa (Group A), no significant differences were observed in the proportion of individuals with zero bleeds, whereas treated total annualized bleeding rate (ABR) and treated spontaneous ABR favored efanesoctocog alfa. Conclusion This indirect comparison suggests that personalized prophylaxis with simoctocog alfa may offer economic advantages versus EHL rFVIII products in individuals with severe hemophilia A. Clinical outcomes were broadly comparable across comparators, although treated total and spontaneous ABRs were significantly lower with efanesoctocog alfa (Group A)."

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

Safety of Damoctocog Alfa Pegol in Patients With Severe Haemophilia A Aged 7 to <12 Years of Age: Pooled Data From PROTECT VIII Kids and Alfa-PROTECT. (PubMed, Haemophilia) - No abstract available

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

Extended Half-Life Recombinant Factor VIII Conjugated with Modifying Substances Does Not Affect Fibrin Clot Formation or Stability in Haemophilia A Blood Samples. (PubMed, Haemophilia) - "People with haemophilia A require treatment with factor VIII (FVIII) to prevent or control bleeding. Some FVIII products are designed to remain active in the body for a longer time, which can reduce the number of injections needed. This extended half-life is achieved by chemically or biologically modifying FVIII, for example by attaching polyethylene glycol (PEG) or the Fc portion of immunoglobulin G. These treatments are known as extended half-life FVIII (EHL-FVIII) products. However, it has not been fully established whether these modifications affect how blood clots form and remain stable. In this study, we compared three EHL-FVIII products with two standard FVIII products using FVIII-deficient blood and plasma. We evaluated clot formation and stability using several laboratory techniques, including whole-blood assays and scanning electron microscopy. We also examined potential differences in anticoagulant and fibrinolytic properties. At comparable FVIII activity..."

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

Accuracy of Factor VIII Assays for Measuring Damoctocog Alfa Pegol: A Comparative Analysis. (PubMed, Haemophilia) - "We have evaluated accuracy results for 19 Factor VIII assays in order to provide evidence-based guidance for clinical laboratories in selecting appropriate assay methodologies for reliable quantification of the activity of Damoctocog alfa pegol. Assay performance should be locally validated as large interlaboratory variation is observed."

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

Sixth interim analysis of the HEM-POWR study: Effectiveness and safety of damoctocog alfa pegol extended dosing regimens in patients with severe and nonsevere hemophilia A (ISTH 2026) - P | "Funded by Bayer. Table or Figure Upload (1) Demographics and clinical characteristics Page 2 Table or Figure Upload (2) ABR by dosing regimen subgroup (mFAS) DOI*10.1016/j.rpth.2026.105939"

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

Real-world effectiveness and safety of damoctocog alfa pegol in adolescent and older patients with hemophilia A in the sixth interim analysis of the HEM-POWR study (ISTH 2026) - P | "Conclusions This interim analysis demonstrated consistent effectiveness and an acceptable benefit-risk profile for damoctocog alfa pegol in adolescent and older PTPs with hemophilia A. Funded by Bayer. Table or Figure Upload (1) Baseline characteristics Page 2 Table or Figure Upload (2) ABR for adolescents and older patients (mFAS N=279) DOI*10.1016/j.rpth.2026.105936"

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

Sixth interim analysis of the HEM-POWR study: Effectiveness and safety of damoctocog alfa pegol in patients with severe and nonsevere hemophilia A by body mass index (ISTH 2026) - P | "Funded by Bayer. Table or Figure Upload (1) Baseline characteristics Page 2 Table or Figure Upload (2) ABR by BMI (mFAS N=279) DOI*10.1016/j.rpth.2026.105919"

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

Comparison of Coagulation and Chromogeic Methods in Pharmacokinetics with Extended Half-life Factor VIII (ISTH 2026) - "Chromogenic substrate assays (CSA) with Coamatic FactorVIII Results A sufficient number to compare results between methods was reached only for the pharmacokinetics with 4 concentrates: 3 FVIII-EHL (Efmoroctocog Alfa (Elocta) - Turoctocog Alfa (Esperoct) - Damoctocog Alfa Pegol (Jivi), all B domain deleted) and a single-chain FVIII (Lonoctocog Alfa (Afstyla). Table or Figure Upload (2) Figure2. DOI*10.1016/j.rpth.2026.104886"

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

Did Efanesoctocog alfa meet our expectations in the prophylaxis of patients with hemophilia A? (ISTH 2026) - "During adolescence, he was treated with octocog alfa and subsequently switched to damoctocog alfa pegol prophylaxis at a regimen of 3000 IU intravenously twice weekly. One patient spontaneously bled into the right ankle after the 5th dose of Efa, absence of individual pharmacokinetic assessment and therefore applies prophylaxis twice a week. Table or Figure Upload (1) Table 1 Baseline characteristics of patients with severe hemophilia A switched to Efa Page 2 Table or Figure Upload (2) Figure 1 FVIII activity over time following switch to Efa in a patient with severe hemophilia A DOI*10.1016/j.rpth.2026.104909"

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

Real-world effectiveness and safety of damoctocog alfa pegol in patients with hemophilia A and a history of inhibitors: Sixth interim analysis of the HEM-POWR study (ISTH 2026) - P | "Conclusions Damoctocog alfa pegol continues to demonstrate effectiveness and an acceptable safety profile in patients with hemophilia A and a history of inhibitors in HEM-POWR. Table or Figure Upload (1) Demographics and clinical characteristics Page 2 Table or Figure Upload (2) ABR in patients with a history of inhibitors (mFAS, n=34) DOI*10.1016/j.rpth.2026.104327"

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

Accuracy of Factor VIII assays for measuring damoctocog alfa pegol: A comparative analysis (ISTH 2026) - "Maximal accepted bias is 20% (dotted line). DOI*10.1016/j.rpth.2026.104087 Page 3"

HA-SAFE: Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding (clinicaltrials.gov) - P=N/A | N=62 | Active, not recruiting | Sponsor: Bayer | Trial completion date: Jun 2028 ➔ Jun 2027

HEOR • Real-world evidence • Trial completion date • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

COST-MINIMIZATION ANALYSIS OF DAMOCTOCOG ALFA PEGOL VERSUS EMICIZUMAB PROPHYLAXIS IN PATIENTS WITH SEVERE HEMOPHILIA A WITHOUT INHIBITORS IN COLOMBIA, PERU AND COSTA RICA (ISPOR 2026) - "Cost minimization analysis presented indicates that damoctocog alfa pegol is a cost-saving alternative, offering over 70% annual cost savings compared to emicizumab in Costa Rica, Colombia, and Peru"

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

A New Risk-Based Scoring Approach to Individualize Prophylaxis in Patients with Hemophilia A: Results from the PREDICT Study. (PubMed, Adv Ther) - P4 | "The PREDICT risk-based scoring system-guided individualized prophylaxis with damoctocog alfa pegol, yielding improved bleeding outcomes and reduced treatment burden in most participants. These findings support the use of structured, risk-adapted approaches to personalize prophylaxis when transitioning from SHL to damoctocog alfa pegol."

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

Sixth Interim Analysis of the HEM-POWR Study: Evaluating Real-World Effectiveness and Safety of Damoctocog Alfa Pegol in Patients With Severe and Nonsevere Hemophilia A in the United States (THSNA 2026) - P | "This subgroup analysis of PTPs from the US in the HEM-POWR study continues to support the favorable effectiveness and safety profile of damoctocog alfa pegol in PTPs with severe and nonsevere hemophilia A. The findings provide insights into real-world clinical practice and can help to inform US stakeholders. Funded by Bayer. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author."

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

HA-SAFE: Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding (clinicaltrials.gov) - P=N/A | N=62 | Active, not recruiting | Sponsor: Bayer | Trial primary completion date: Jun 2028 ➔ Mar 2027

HEOR • Real-world evidence • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Bayer | N=600 ➔ 20

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

Plain Language Summary on Safety and Efficacy of Damoctocog Alfa Pegol in Previously Treated Children Aged 7 to < 12 Years With Severe Haemophilia A in the Phase 3, Open Label Alfa-PROTECT Main Study. (PubMed, Eur J Haematol) - P3 | "This is a plain language summary describing results from the Alfa-PROTECT study on safety and efficacy of damoctocog alfa pegol in previously treated children aged between 7 and 12 years with severe haemophilia A. Trial Registration: The Alfa-PROTECT trial is registered at ClinicalTrials.gov: NCT05147662."

Journal • P3 data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

HEM-POWR Kids: An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A (clinicaltrials.gov) - P=N/A | N=40 | Not yet recruiting | Sponsor: Bayer | Initiation date: Dec 2025 ➔ Apr 2026

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

Safety and Efficacy of Damoctocog Alfa Pegol in Previously Treated Children Aged 7 to < 12 Years With Severe Haemophilia A in the Phase 3, Open Label Alfa-PROTECT Main Study. (PubMed, Eur J Haematol) - P3 | "These data confirm the safety profile of damoctocog alfa pegol in children aged 7 to < 12 years with severe haemophilia A. Secondary endpoints indicate treatment was efficacious."

Journal • P3 data • Hematological Disorders • Hemophilia • Hemophilia A • Immunology • Rare Diseases

HEM-POWR Kids: An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A (clinicaltrials.gov) - P=N/A | N=40 | Not yet recruiting | Sponsor: Bayer | Trial primary completion date: Oct 2029 ➔ Dec 2029

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

A risk-based scoring approach to individualize prophylaxis in patients with Hemophilia A: Results from the predict study (ASH 2025) - "The Phase 4 PREDICT study evaluated whether a structured risk-based scoring system could guide personalized prophylaxis in patients transitioning from standard half-life (SHL) FVIII products to the extended half-life (EHL) therapy damoctocog alfa pegol...Significant reductions in bleeding, infusion frequency, and near-complete resolution of baseline target joints (96%) were observed. These findings support the feasibility and clinical utility of a structured risk-based algorithm to optimize EHL prophylaxis, improve outcomes, and meaningfully reduce treatment burden during SHL-to-EHL transitions."

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

A risk-based scoring approach to individualize prophylaxis in patients with Hemophilia A: Results from the predict study (ASH 2025) - "The PREDICT scoring system helped to guide individualized prophylaxis regimens with damoctocog alfapegol, leading to favorable outcomes in 77% and 71% of participants, based on treated and total ABRs,respectively. Although limited by a small sample size, these findings provide early evidence that a risk-based scoring approach, incorporating patients' clinical and intrinsic characteristics, may support HCPsand patients globally as a valuable clinical guide in personalizing their prophylaxis regimen whentransitioning from an SHL to an extended-half-life (EHL)-based regimen, like damoctocog alfa pegol."

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

First report of high-titer FVIII inhibitor development following AAV-mediated gene therapy in Hemophilia A (ASH 2025) - "Prior to enrollment, he was on damoctocog alfa pegol prophylaxis (>150 ED)...After the 3rd CS course discontinuation (D335), FVIII:Ccontinued to decrease (1.1 to 0.2 IU/mL) leading to the initiation of mycophenolate mofetil (MMF) and CSwere reintroduced...In response,MMF was increased to 1 g twice daily on D455 to support inhibitor eradication, and emicizumabprophylaxis was initiated on D460 (225 mg QW)...A positive total IgG titer was firstdetected on D219 (~4 months prior to the first positive inhibitor result), however a first IgG3 titer >positive cutoff was detected on D23. IgG1 and IgG3 were the predominant subclasses.To our knowledge this is the first reported case of high-titer FVIII inhibitor development following genetherapy in a patient with hemophilia A. Although this appears to be a rare event, potentially comparableto or even less frequent than inhibitor formation in previously treated patients receiving FVIIIprophylaxis, these results suggest that the..."

Gene therapy • Gene Therapies • Hematological Disorders • Hemophilia • Hemophilia A • Human Immunodeficiency Virus • Immune Thrombocytopenic Purpura • Infectious Disease • Rare Diseases • Thrombocytopenia • Thrombocytopenic Purpura

Real-World Data on Hemophilia a Patients Transitioning from Bay 81-8973 to Bay 94-9027 and from Bay 14-2222 to Bay 81-8973 and then to Bay 94-9027 in the Athndataset (ASH 2023) - "Patients with Hemophilia A are transitioning more and more from standard half-life (SHL) products to extended half-life (EHL) recombinant factor VIII (rFVIII) productsObjective: To evaluate the effect of Hemophilia A patients transitioning from BAY 81-8973 (Kovaltry ®) to BAY 94-9027 (Jivi ®) and from BAY 14-2222 (Kogenate FS ®) to BAY 81-8973 and then to BAY 94-9027 in a real-world setting. The data show that hemophilia A patients who transitioned to BAY 94-9027 from BAY 81-8973, or those that transitioned from BAY 14-2222 to BAY 81-8973 and then to BAY 94-9027 did experience similar or decreased total annual bleed rates with a decrease in their prophylaxis regimen frequency when transitioning to BAY 94-9027 in the real world. The therapeutic burden of frequent infusions can be reduced when patients transition between rFVIII product classes (SHL to EHL), without change in their annual bleed rate. These data should be interpreted with caution owing to..."

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