Explore data below on Kogenate FS patients who transitioned to Kovaltry as part of a clinical trial.
Study Design
The multinational, open-label prospective study of previously treated patients aged 12-65 years with severe hemophilia A evaluated efficacy and safety of Kovaltry 2x/week (n=18) or 3x/week (n=44) prophylaxis. The primary efficacy endpoint was annualized bleed rate (ABR) at 12 months.2
1 Median
ABR
(n=62)
(IQR=0.0; 5.1)12
Median dose:
31.2 IU/kg
(range: 21-43 IU/kg)12
in 62 previously treated patients2
People with hemophilia A may develop inhibitors to rFVIII.2*
The most frequently reported adverse reactions in clinical trials (≥5%) were inhibitors in previously untreated patients (PUPs)/minimally treated patients (MTPs), and pyrexia, headache and rash.
ABR, annualized bleed rate.
IQR=interquartile range.
*People with a history of inhibitors were excluded from LEOPOLD I9
22 adolescent and adult Kogenate FS patients transitioned to Kovaltry prophylaxis as part of the LEOPOLD I clinical trial.9
Kogenate FS patients experienced fewer annual bleeds after transitioning to Kovaltry9†
Median ABR
(n=22)
(IQR=0.0; 9.0)9
1
Median
ABR
(n=22)
(IQR=0.0; 6.8)9
Median dose:
35.4 IU/kg
(range: 23.99-49.26)9
in the subgroup analysis of 22 previously treated patients9
People with hemophilia A may develop inhibitors to rFVIII.9‡
There were no drug-related adverse events in this subgroup during the 12 months of the main trial.
ABR, annualized bleed rate.
IQR=interquartile range.
*Prior Kogenate FS or Helixate FS dose not calculated or not available.9
†Self-reported bleeds in prior 12 months.9
‡People with a history of inhibitors were excluded from LEOPOLD I.9
Kogenate FS | Kovaltry | |||
---|---|---|---|---|
Dose |
25 IU/kg
|
20 IU/kg 40 IU/kg | Potential to stay on the same dose | |
|
||||
Frequency |
3x per week
|
3x per week 2x per week
|
Potential to stay on the same infusion frequency or reduce frequency |
Kogenate FS | Kovaltry | |
---|---|---|
Dose | 25 IU/kg Potential to stay on the same dose | 20 IU/kg 40 IU/kg |
Frequency | 3x per week Potential to stay on the same infusion frequency or reduce frequency | 3x per week 2x per week |
*Self-reported bleeds in prior 12 months.9
The safety and efficacy of Kovaltry for on-demand treatment in adolescent and adult (12 to 65 years of age) previously treated patients (PTPs) was evaluated for 12 months2,15
95.2%
of bleeds were treated
with ≤2 infusions15
75.5%
1 infusion15
19.7%
2 infusions15
4.8%
3+ infusions15
21.6% of total bleeds were trauma bleeds.15
0 inhibitors
in the main study analysis of 21 previously treated patients.15
One patient in the on-demand group (n=21) experienced a mild drug-related adverse event (infusion site pruritus).15
The on-demand arm in the LEOPOLD II clinical trial and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.15
10 Kogenate FS on-demand patients transitioned to Kovaltry on-demand as part of the clinical trial.15
96.7%
of bleeds were treated
with ≤2 infusions15
85.9%
1 infusion15
10.8%
2 infusions15
3.3%
3+ infusions15
15.9% of total bleeds were trauma bleeds.15
0 inhibitors
in the subgroup analysis of 10 previously treated patients.15
There were no drug-related adverse events in the subgroup.16
The on-demand arm in the LEOPOLD II clinical trial and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.15
For more information on Kovaltry, visit the Kovaltry website.
Click here to go to the Resources page where you can download this information.
1. Kogenate Prescribing Information. Bayer HealthCare LLC, Whippany, NJ. 2. Kovaltry Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2021. 9. Data on file. Leopold I (12954) prior Kogenate FS/Helixate FS cohort. Bayer HealthCare LLC, Whippany, NJ; 2016. 11. Data on File. Kovaltry Summary Basis for Regulatory Action. Bayer HealthCare LLC, Whippany, NJ; 2016. 12. Saxena K, Lalezari S, Oldenburg J, et al. Efficacy and safety of BAY 81-8973, a full-length recombinant factor VIII: results from the LEOPOLD I trial. Haemophilia. 2016;22(5):706-712. 15. Data on file. Leopold II (14319) prior OD Kogenate FS/Helixate FS Cohort - Descriptive Analysis. Bayer Healthcare LLC, Whippany, NJ. 16. Data on file. Leopold II (14319) prior OD Kogenate FS/Helixate FS Cohort. Bayer HealthCare LLC, Whippany, NJ.
KOGENATE FS is an Antihemophilic Factor (Recombinant) indicated for:
KOVALTRY Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A for:
JIVI antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:
KOGENATE FS, KOVALTRY, and JIVI are not indicated for the treatment of von Willebrand disease.
In clinical trials with:
For additional important risk and use information, please see the full Prescribing Information for KOGENATE FS, KOVALTRY, and JIVI.