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11 Diseases |  |
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- | Hemlibra (emicizumab-kxwh) / Roche
Journal: Development of a Rapid and Fully Automated Factor VIII-Inhibitor Assay, Insensitive for Emicizumab, and a Lowest Level of Quantification of 0.2BU/mL. (Pubmed Central) - Sep 21, 2024
We present development data of a sensitive and specific rapid, automated FVIII inhibitor assay generating results within 20 minutes that is less resource-intensive than standard assays with potential to improve assay variability.
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Population pharmacokinetics model of BAY81-8973 in Chinese children with severe haemophilia A (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_1242;
VWF:Ag and blood type were significant descriptors of clearance (CL) and volume of central compartment (V1). Fat free mass (FFM) was a significant descriptor of CL, volume of peripheral compartment (V1 & V2).
- ||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion date: Drug Use Investigation of Kovaltry in Hemophilia A Patients (clinicaltrials.gov) - Mar 28, 2024
P=N/A, N=231, Active, not recruiting, Sponsor: Bayer
Fat free mass (FFM) was a significant descriptor of CL, volume of peripheral compartment (V1 & V2). Trial completion date: Mar 2024 --> Sep 2025
- | Kovaltry (octocog alfa) / Bayer, CSL Behring
New P4 trial: A Post Approval Commitment study to evaluate the efficacy, safety, and pharmacokinetics of KOVALTRY in Chinese children, adolescents/adults with severe hemophilia A. (EUDRACT) - Mar 14, 2024
P4, N=48, , Sponsor: Bayer Healthcare Company Limited
- Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer
TITLE: REAL-WORLD EFFICACY DATA ON ADOLESCENT HEMOPHILIA A PATIENTS TRANSITIONING TO BAY 81-8973 OR BAY 94-9027 IN THE ATHNDATASET (Riverwalk AB; Virtual) - Mar 2, 2024 - Abstract #THSNA2024THSNA_237;
The therapeutic burden of frequent infusions can be reduced and treatment efficacy can be improved when adolescent patients transition to either BAY94-9027 or BAY81?8973. These data should be interpreted with caution owing to limitations of real-world studies.
- | Jivi (damoctocog alfa pegol) / Bayer, Advate (octocog alfa) / Takeda
Journal: Canadian clinical experience on switching from standard half-life recombinant factor VIII (rFVIII), octocog alfa, to extended half-life rFVIII, damoctocog alfa pegol, in persons with haemophilia A ? 12 years followed in a Comprehensive Hemophilia Care Program in Canada. (Pubmed Central) - Feb 21, 2024
These data should be interpreted with caution owing to limitations of real-world studies. This study provides routine clinical evidence supporting the benefits of switching from octocog alfa to damoctocog alfa pegol for patients with severe haemophilia A.
- | Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
Journal: Switching from Sucrose-Formulated rFVIII to Octocog Alfa (BAY 81-8973) Prophylaxis Improves Bleed Outcomes in the LEOPOLD Clinical Trials. (Pubmed Central) - Jun 13, 2023
P3
This study provides routine clinical evidence supporting the benefits of switching from octocog alfa to damoctocog alfa pegol for patients with severe haemophilia A. Previous clinical trials established the efficacy and safety of sucrose-formulated recombinant factor (F) VIII (rFVIII-FS/Kogenate FS
- | Journal: Relationship between factor VIII levels and bleeding for rFVIII-SingleChain in severe hemophilia A: A repeated time-to-event analysis. (Pubmed Central) - May 22, 2023
In conclusion, the developed PK-RTTE model adequately described the relationship between dose, FVIII levels and bleeds for rFVIII-SingleChain. The obtained estimates were in agreement with those published for the FVIII concentrates BAY 81-8973 (octocog alfa) and BAY 94-9027 (damoctocog alfa pegol), indicating similar efficacy to reduce bleeding.
- Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer
Title: Real-World data on Hemophilia A patients with inhibitors switching to either BAY 94-9027 or BAY 81-8973 in the ATHNdataset (Room:Exhibition) - May 18, 2023 - Abstract #ISTH2023ISTH_1911;
- Hemlibra (emicizumab-kxwh) / Roche, Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer
Real-World data on Hemophilia A patients switching to either BAY 94-9027 or BAY 81-8973 from Emicizumab using the ATHNdataset (Room:Exhibition) - May 18, 2023 - Abstract #ISTH2023ISTH_1347;
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion date, Trial primary completion date: A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A (clinicaltrials.gov) - May 18, 2023
P4, N=48, Recruiting, Sponsor: Bayer
The obtained estimates were in agreement with those published for the FVIII concentrates BAY 81-8973 (octocog alfa) and BAY 94-9027 (damoctocog alfa pegol), indicating similar efficacy to reduce bleeding. Trial completion date: Aug 2024 --> Sep 2028 | Trial primary completion date: Aug 2024 --> Sep 2028
- Jivi (damoctocog alfa pegol) / Bayer, Advate (octocog alfa) / Takeda
GERMAN CLINICAL EXPERIENCE OF SWITCHING FROM OCTOCOG ALFA TO DAMOCTOCOG ALFA PEGOL IN PATIENTS WITH HAEMOPHILIA A () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_373;
Trial completion date: Aug 2024 --> Sep 2028 | Trial primary completion date: Aug 2024 --> Sep 2028 Introduction: Damoctocog alfa pegol (BAY 94-9027, Jivi
- Xyntha (moroctocog alfa) / Pfizer, Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
CLINICAL APPLICATION OF LONG ACTING FACTOR VIII PRODUCT LONOCTOCOG IN CHILDREN WITH HAEMOPHILIA A () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_321;
All patients (apart from one with mild haemophilia) had been previously treated with recombinant FVIII concentrates [SHL: Advate (Takeda), Kovaltry (Bayer) and Refacto (Pfizer)] for more than 100 EDs (Exposure Days). This study demonstrates the successful transition of CWH A from SHL to Lonoctocog.
- | Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion date: Drug Use Investigation of Kovaltry in Hemophilia A Patients (clinicaltrials.gov) - Jan 17, 2023
P=N/A, N=231, Active, not recruiting, Sponsor: Bayer
This study demonstrates the successful transition of CWH A from SHL to Lonoctocog. Trial completion date: Mar 2023 --> Mar 2024
- | Kovaltry (octocog alfa) / Bayer, CSL Behring
Journal: BAY 81-8973 Efficacy and Safety in Previously Untreated and Minimally Treated Children with Severe Hemophilia A: The LEOPOLD Kids Trial. (Pubmed Central) - Jan 11, 2023
Overall, the BAY 81-8973 benefit-risk profile remains unchanged and supported by ongoing safety surveillance. Immune tolerance can be achieved with BAY 81-8973.
- Kovaltry (octocog alfa) / Bayer, CSL Behring, Haemoctin (human plasma derived coagulation factor VIII) / ADMA Biologics
Low resolution cryo-EM maps and AFM analysis combined with alpha fold model of full-length coagulation Factor VIII sheds light on the conformational positioning of the Factor VIII B domain (#51) (Spectrum (C2)) - Jan 7, 2023 - Abstract #GTH2023GTH_185;
Conclusion The FL-FVIII shows a significant amount of conformational variability, most of which is attributed to the disordered B domain. Glycosylation plays a key role in the folding and stabilization of the B domain with respect to the rest of the FL-FVIII.
- | Journal: Area under the curve: Comparing the value of factor VIII replacement therapies in haemophilia A. (Pubmed Central) - Nov 30, 2022
This analysis concludes that EHL products differ in relative AUC, have a larger AUC compared with standard half-life, and thus, different FVIII levels over time after infusion. This model may aid decision makers in the absence of head-to-head data.
- IDO 8 / Idogen
Trial in Progress: An Open-Label, Multi-Center, First in Human, Phase 1/2a Trial to Evaluate the Safety and Preliminary Efficacy of Autologous Tolerogenic Dendritic Cells Ex Vivo Loaded with Recombinant Factor VIII (FVIII) in Adults with Congenital Hemophilia a (HA) with Neutralizing Antibodies to FVIII and Having Failed Immune Tolerance Induction (ITI) () - Nov 29, 2022 - Abstract #ASH2022ASH_7797;
The first subject is planned to be enrolled in August 2022. The trial is approved by the Swedish and Norwegian Competent Authorities and by the Swedish Ethical Review Authority (July 2022) and will also be reviewed by EU and UK Authorities.
- Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer, Advate (octocog alfa) / Takeda
A Real-World Population Pharmacokinetic (PK) Study of Two Recombinant Factor VIII (rFVIII) Concentrates in Boys with Severe Hemophilia a without Inhibitors (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_5583;
Aim To determine the accuracy of a clinically practical single-clinic visit, reverse 2-sampling time point population PK protocol for generating individual PK profiles [clearance (Cl) and terminal half-life (t1/2)] in boys with severe hemophilia A without inhibitors receiving either an SHL [antihemophilic factor (recombinant) BAY 81-8973 (Kovaltry®)] or an extended half-life (EHL) FVIII concentrate [antihemophilic factor (recombinant) PEGylated BAY 94-9027 (Jivi®)] for long-term prophylaxis...Conclusion The reverse 2-point, single clinic visit, PK protocol (24/48 or 72h and 3h) is a practical approach to generate PK parameters that provide clinically useful information for guiding personalized prophylaxis regimens for boys receiving SHL or EHL for long-term prophylaxis. Funding Supported by Bayer (Investigator-Initiated Research grant)
- Jivi (damoctocog alfa pegol) / Bayer, Advate (octocog alfa) / Takeda
Real-World Use of Octocog Alfa and Damoctocog Alfa Pegol in Women with Hemophilia a from the ATHNdataset (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_1988;
We used the ATHNdataset to identify female patients who received octocog alfa (BAY 81-8973/Kovaltry®) or damoctocog alfa pegol (BAY 94-9027/Jivi®) between January 1, 2010 and April 30, 2022...Two patients on damoctocog alfa pegol with known data were previously treated with another product, one episodically with desmopressin and the other prophylactically with an extended half-life product...Three patients treated with different products before using octocog alfa had spontaneous, joint and traumatic bleeds on their previous therapies. More data are needed on the diagnosis and treatment of women with hemophilia A.
- | Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
Journal, Real-world evidence: Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS. (Pubmed Central) - Oct 5, 2022
P=N/A
More data are needed on the diagnosis and treatment of women with hemophilia A. These data show that a smooth transition is observed when switching to octocog alfa from a previous FVIII treatment, with no safety issues and stable bleeding rates in a real-world setting of patients with moderate-to-severe haemophilia A.
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion date, Trial primary completion date: A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A (clinicaltrials.gov) - Oct 3, 2022
P4, N=48, Recruiting, Sponsor: Bayer
These data show that a smooth transition is observed when switching to octocog alfa from a previous FVIII treatment, with no safety issues and stable bleeding rates in a real-world setting of patients with moderate-to-severe haemophilia A. Trial completion date: Jan 2025 --> Aug 2024 | Trial primary completion date: Jan 2025 --> Aug 2024
- || Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer
Trial termination: Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry (clinicaltrials.gov) - Aug 25, 2022
P=N/A, N=3, Terminated, Sponsor: Bayer
Trial completion date: Jan 2025 --> Aug 2024 | Trial primary completion date: Jan 2025 --> Aug 2024 Completed --> Terminated; Insufficient data
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
PK/PD data, Journal: Pharmacokinetic parameter driven outcomes model predicts a reduction in bleeding events associated with BAY 81-8973 versus antihemophilic factor (recombinant) plasma/albumin-free method in a Chinese healthcare setting. (Pubmed Central) - Aug 14, 2022
Based on modeled head-to-head comparisons, differences in PK-properties between BAY 81-8973 and rAHF-PFM result in a reduced number of bleeding events, leading to reduced costs and increased quality of life for BAY 81-8973. These results should be used to inform clinical practice in China when caring for patients with severe hemophilia A.
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion date, Trial primary completion date: A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A (clinicaltrials.gov) - Aug 8, 2022
P4, N=48, Recruiting, Sponsor: Bayer
These results should be used to inform clinical practice in China when caring for patients with severe hemophilia A. Trial completion date: Aug 2024 --> Jan 2025 | Trial primary completion date: Aug 2024 --> Jan 2025
- | Eloctate (efraloctocog alfa) / Sanofi, SOBI, Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
Journal, Real-world evidence: Analysis of pooled real-world data from Germany, Italy, and the United States of rVIII-SingleChain compared with standard- and long-acting FVIII products for prophylaxis of hemophilia A. (Pubmed Central) - Jul 8, 2022
Similar trends were observed for all outcomes when analyzing the subgroups of patients aged ≥12 years and patients with severe disease (all age and ≥12 years). rVIII-SingleChain prophylaxis may provide improved bleed protection, less frequent dosing, and lower consumption compared with standard-acting FVIII products, and comparable protection and consumption to the other long-acting FVIII product, in patients with hemophilia A.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
Clinical data, Journal, Real-world evidence: Real-World Clinical Outcomes and Replacement Factor VIII Consumption in Patients with Haemophilia A in Italy: A Comparison between Prophylaxis Pre and Post Octocog Alfa (BAY 81-8973). (Pubmed Central) - Jun 25, 2022
Patients treated every 3 days or 2 times per week increased from 0% to 27.3%. (4) our results suggest that prophylaxis with BAY 81-8973 can improve clinical outcomes and reduce FVIII consumption, in the real-world practice, compared with the previous prophylaxis regimen with standard half-life products.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer
Trial completion, Enrollment change: Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry (clinicaltrials.gov) - Jun 10, 2022
P=N/A, N=3, Completed, Sponsor: Bayer
(4) our results suggest that prophylaxis with BAY 81-8973 can improve clinical outcomes and reduce FVIII consumption, in the real-world practice, compared with the previous prophylaxis regimen with standard half-life products. Recruiting --> Completed | N=128 --> 3
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment closed, Enrollment change: Drug Use Investigation of Kovaltry in Hemophilia A Patients (clinicaltrials.gov) - May 19, 2022
P=N/A, N=231, Active, not recruiting, Sponsor: Bayer
Recruiting --> Completed | N=128 --> 3 Recruiting --> Active, not recruiting | N=30 --> 231
- Jivi (damoctocog alfa pegol) / Bayer, Advate (octocog alfa) / Takeda
Canadian Patient Experience on Switching from Octocog Alfa to Extended Half-Life FVIII Damoctocog Alfa Pegol in Patients with Severe Hemophilia A (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1764;
Median annualized bleeding rates following the switch to damoctocog alfa pegol are shown in Table 1. For damoctocog alfa pegol vs octocog alfa, the median (Q1;Q3) number of infusions per week was 2.20 (2.01;2.98) vs 2.67 (2.09;2.93), respectively and the median annualized recorded FVIII utilization was 3819.6 (2980.9;4564.8) vs 4348.7 (3769.0;5156.5) IU/kg/year, respectively.
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Enhanced pharmacokinetics and improved clinical outcomes in young hemophiliac boys after the switch to BAY 81-8973 from other standard half-life FVIII concentrates (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1174;
For damoctocog alfa pegol vs octocog alfa, the median (Q1;Q3) number of infusions per week was 2.20 (2.01;2.98) vs 2.67 (2.09;2.93), respectively and the median annualized recorded FVIII utilization was 3819.6 (2980.9;4564.8) vs 4348.7 (3769.0;5156.5) IU/kg/year, respectively. Longer half-life time (t1/2)[Kogenate FS group:14.36±1.92 vs. 11.92±2.41h,P < 0.0001); Advate group(13.41±1.44 vs. 9.67±1.74h,P < 0.0001); GreenMono group(15.07±3.36 vs.
- Eloctate (efraloctocog alfa) / Sanofi, SOBI, Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
Budget impact of increasing rVIII-SingleChain use in patients in Italy with moderate and severe hemophilia A (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_246;
These findings remained consistent when regional acquisition costs were used instead of list prices. Conclusion(s): Increasing utilization of rVIII-SingleChain in the treatment of patients with hemophilia A may lead to cost-savings as a result of reduced FVIII consumption.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
PK/PD data, Journal: Inter-individual variability in pharmacokinetics and clinical features in pediatric patients with severe hemophilia A. (Pubmed Central) - Apr 26, 2022
Conclusion(s): Increasing utilization of rVIII-SingleChain in the treatment of patients with hemophilia A may lead to cost-savings as a result of reduced FVIII consumption. This study revealed the great inter-individual variability in PK parameters, clinical bleeding phenotype and joint vulnerability, which all should be considered in treating hemophilia A.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
PK/PD data, Journal: Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half-life factor VIII concentrates. (Pubmed Central) - Apr 1, 2022
Participants who switched to Kovaltry from three other FVIII concentrates with the same dosing regimens obtained higher trough FVIII levels and better protection with reduced annualized bleeding rates. Compared with Kogenate FS, Advate, and GreenMono, Kovaltry showed enhanced PK profiles, which contributed to reduced bleeding rates.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Clinical, Clinical data, Journal: Clinical outcome and adherence rate in Scandinavian patients with intermediate-intensity prophylaxis before and after the switch of standard half-life FVIII products to BAY 81-8973. (Pubmed Central) - Mar 15, 2022
Compared with Kogenate FS, Advate, and GreenMono, Kovaltry showed enhanced PK profiles, which contributed to reduced bleeding rates. Concentrate switch, using mainly intermediate-intensity regimens with high adherence rates, preserves excellent prophylaxis outcome using standard half-life FVIII products, indicating the value of individualized prophylaxis and close follow-up.
- CLINICAL APPLICATION OF EXTENDED HALF-LIFE PEGYLATED FACTOR VIII IN CHILDREN WITH SEVERE HAEMOPHILIA A ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_231;
Five children (63%) switched to Adynovi (Baxalta), two to Jivi (Bayer) and one to Esperoct (Novo Nordisk)... This study demonstrates the successful transition of eight CWH A from SHL to pEHL factor concentrates.
- Jivi (damoctocog alfa pegol) / Bayer, Advate (octocog alfa) / Takeda
CANADIAN CLINICAL EXPERIENCE ON SWITCHING FROM OCTOCOG ALFA TO EXTENDED-HALF-LIFE FVIII DAMOCTOCOG ALFA PEGOL IN PATIENTS WITH SEVERE HAEMOPHILIA A ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_228;
PK parameters and time to FVIII thresholds (increment of ∼1 day) were improved with damoctocog alfa pegol compared with octocog alfa. These data provide real-world evidence supporting the enhanced PK properties of damoctocog alfa pegol compared with octocog alfa.
- Eloctate (efraloctocog alfa) / Sanofi, SOBI, Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
BUDGET IMPACT OF RVIII-SINGLECHAIN IN MODERATE AND SEVERE HAEMOPHILIA A TREATMENT IN ITALY ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_227;
Mean product consumption and mean annual bleeding rate for rVIII-SingleChain, rFVIIIFc, octocog alfa and BAY 81–8973 were based on pooled real-world data from Italy and Germany... Increasing utilization of rVIII-SingleChain in haemophilia A patients may lead to cost-savings as a result of reduced consumption with uncompromised efficacy in bleed protection.
- AREA UNDER THE CURVE: INDIRECT PRODUCT COMPARISONS BETWEEN FACTOR VIII REPLACEMENT THERAPIES IN HAEMOPHILIA A ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_221;
In Scenarios 1 and 3, Jivi showed the largest AUC, and in Scenario 2, AUCs of EHLs Elocta and Adynovi were larger than Advate. This AUC tool may aid decision makers in comparing the relative value of FVIII concentrates in the absence of head-to-head trials.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer, Adynovate (rurioctocog alfa pegol) / Takeda
PK/PD data, Journal: Comparison of the Pharmacokinetic Properties of Extended Half-Life and Recombinant Factor VIII Concentrates by In Silico Simulations. (Pubmed Central) - Dec 16, 2021
BAY 81-8973 and rFVIII-SC showed smaller PK improvements. Although our analyses increase insight into the PK of these FVIII concentrates, more studies evaluating the relation between factor levels and bleeding risk are needed.
- || Advate (octocog alfa) / Takeda
Clinical, PK/PD data, Journal: External qualification of the Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-Hemo) models for octocog alfa using real patient data. (Pubmed Central) - Nov 16, 2021
Qualification of population PK models and their use for Bayesian forecasting in full and reduced sampling is an essential step toward their validation. The evaluations performed in this study support the confidence of PK parameter estimates provided by the models.
- | Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer
Journal: The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX Assay. (Pubmed Central) - Oct 28, 2021
In the FVIII assay, the peak time measured with sTF/FIX did not differ markedly between Jivi and Kovaltry; however, the FVIII activity in Jivi (as measured by the peak height) tended to be higher than in Kovaltry. The CWA findings for monitoring Jivi varied for monitoring Jivi depending on the APTT reagents used, and sTF/FIX assay may be able to measure the EHL-FVIII.
- Eloctate (efraloctocog alfa) / Sanofi, SOBI, Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
Pooled real-world data of rVIII-SingleChain compared with standard- and long-acting FVIII products for prophylaxis of haemophilia A in Germany, Italy, and the United States () - Oct 18, 2021 - Abstract #ECTH2021ECTH_91;
De-identified patient chart data were collected from treatment centres in Germany, Italy, and the US and combined for rVIII-SingIeChain, two SA FVIII products (octocog alfa and BAY 81-8973) and one LA rFVIII (rFVIIIFc). These data demonstrate that prophylaxis with rVIII-SingIeChain may provide improved bleed protection, less frequent dosing, and lower consumption compared with the two SA products, and it is comparable to the LA product.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring, Kogenate FS (octocog alfa sucrose formulation) / CSL Behring, Bayer
Clinical, PK/PD data, Journal: Comparative pharmacokinetics of Kogenate FS and Kovaltry in 14 Chinese paediatric patients with haemophilia A: A single-centre study. (Pubmed Central) - Sep 26, 2021
These data demonstrate that prophylaxis with rVIII-SingIeChain may provide improved bleed protection, less frequent dosing, and lower consumption compared with the two SA products, and it is comparable to the LA product. No abstract available
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Clinical, Clinical data, PK/PD data, Journal: Pharmacokinetic-guided prophylaxis improved clinical outcomes in paediatric patients with severe haemophilia A. (Pubmed Central) - Sep 26, 2021
No abstract available PK-guided prophylaxis can help haemophiliac patients improve quality of life by decreasing bleeds with appropriate FVIII consumption and reducing infusion frequency without increments in bleeds, thus optimizing haemophilia treatment.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Clinical, PK/PD data, Journal: Pharmacokinetic study of Kovaltry in thirty-five pediatric patients aged <12 years with severe hemophilia A. (Pubmed Central) - Sep 22, 2021
VWF:Ag and blood group were major influencing factors of t and CL of Kovaltry, while BMI was a vital predictor for IVR. Patients with high trough FVIII level in routine prophylaxis had reduced bleeding rates.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Clinical, Journal: Tailoring haemophilia A prophylaxis with BAY 81-8973: A case series. (Pubmed Central) - Aug 7, 2021
We here report on a retrospective case series of nine patients affected by hemophilia A (HA), with variable disease severity, bleeding phenotype and comorbidities, to underline our clinical practice on prophylaxis with a recently introduced standard hall-life recombinant Factor VIII. The current case series highlights how the current clinical management of hemophilia is able to personalize treatment in several specific conditions like concomitant illnesses with thrombotic risk and allergic reactions.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Clinical, Clinical protocol, PK/PD data, Journal: Pharmacokinetics and complementary evaluation system-based guidance on prophylaxis of paediatric patients with haemophilia A in China with Kovaltry: protocol of the LEAP study. (Pubmed Central) - Aug 6, 2021
Related manuscripts will be submitted to peer-review journals such as Blood and Hemophilia. ChiCTR2000037821; Pre-results.
- | Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion date: Drug Use Investigation of Kovaltry in Hemophilia A Patients (clinicaltrials.gov) - Jul 7, 2021
P=N/A, N=30, Recruiting, Sponsor: Bayer
ChiCTR2000037821; Pre-results. Trial completion date: Sep 2022 --> Mar 2023
- || Clinical, Journal, Real-world evidence: A Real-World Analysis of Commonly Prescribed FVIII Products Based on U.S. Medical Charts: Consumption and Bleeding Outcomes in Hemophilia A Patients. (Pubmed Central) - Jul 4, 2021
The 6 products evaluated showed statistically comparable ABRs and percentage of patients with 0 bleeds for all patients including those with severe disease. rVIII-SingleChain demonstrated lowest mean consumption for all patients, as well as for patients with severe hemophilia A, which may lead to potential savings in health care costs.