Explore data below on Kogenate FS pediatric patients who transitioned to Kovaltry as part of a clinical trial.
Study Design
The multinational, open-label study evaluated efficacy and safety of routine prophylaxis either 2 times per week, 3 times per week, or every other day with Kovaltry in previously treated patients (≤12 years) with severe hemophilia A. The primary efficacy endpoint, ABR within 48 hours after prophylactic infusion, was 0 (0.0; 4.0).2
1.9 Median
ABR
0-12 years
(n=51)
(IQR=0.0; 6.0)2
0-<6 years Median dose: 36.4 IU/kg (range: 21-58 IU/kg)2 | 6-12 years Median dose: 31.8 IU/kg (range: 22-50 IU/kg)2 |
in 51 previously treated patients2‡
‡No confirmed cases of neutralizing antibodies (inhibitors) to FVIII occurred.
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.
†One case of transient low titer inhibitor (0.6 BU/mL (peak titer: 1.0 BU/mL)) occurred in a 13 year old PTP after 549 EDs concurrent with an acute infection and positive IgG anticardiolipin antibodies. The Factor VIII recovery was normal (2.7 IU/dL per IU/kg). annualized bleeding rate (ABR) was zero, and no change in therapy was required.2
ABR, annualized bleed rate.
IQR=interquartile range.
†People with a history of inhibitors and previously untreated children were excluded from LEOPOLD Kids.10
18 pediatric Kogenate FS patients transitioned to Kovaltry prophylaxis as part of the LEOPOLD Kids clinical trial.10
Kogenate FS patients experienced fewer annual bleeds after transitioning to Kovaltry10*
Median ABR
0-12 years (n=18)
(IQR=0.0; 6.0)10
0.0 Median
ABR
0-12 years
(n=18)
(IQR=0.0; 6.02)10
0-<6 years (n=11)
Median dose:
34 IU/kg (range: 23 - 56 IU/kg)10 |
6-12 years (n=7)
Median dose:
37.6 IU/kg (range: 23 - 47 IU/kg)10 |
in the subgroup analysis of 18 previously treated patients10
People with hemophilia A may develop inhibitors to rFVIII.10*
There were no drug-related adverse events in this subgroup.
ABR, annualized bleed rate.
IQR=interquartile range.
*Self-reported bleeds in prior 12 months.
†People with a history of inhibitors and previously untreated children were excluded from LEOPOLD Kids.9
Kogenate FS | Kovaltry | |||
---|---|---|---|---|
Dose | 25 IU/kg | 25 IU/kg 50 IU/kg | Potential to stay on the same dose | |
Frequency | Every other day | Every other day 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 | 25 IU/kg 50 IU/kg |
Frequency | Every other day Potential to stay on the same infusion frequency or reduce frequency | Every other day 3x per week 2x per week |
*Self-reported bleeds in prior 12 months.
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; 2016. 8. Data on file. Jivi Protect VIII Subgroup Analysis. Bayer HealthCare LLC, Whippany, NJ. 9. Data on file. Leopold I (12954) prior Kogenate FS/Helixate FS cohort. Bayer HealthCare LLC, Whippany, NJ. 10. Data on file. LEOPOLD Kids Subgroup Analysis. Bayer HealthCare LLC, Whippany, NJ. 11. Data on File. Kovaltry Summary Basis for Regulatory Action. Bayer HealthCare LLC, Whippany, NJ; 2016.
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.