KOVALTRY Efficacy & Safety: Children

LEOPOLD Kids Trial: Main Study

Proven efficacy and safety in previously treated children with prophylaxis using as few as 2 infusions per week¹

Child LEOPOLD I Clinical Trial Main Study

ABR for Total Bleeds¹

Graphic displaying ABR total bleeds in primary endpoint and secondary endpoint with Kovaltry

*During the LEOPOLD Kids study, one patient was moved from a 2x/week prophylaxis regimen to a 3x/week prophylaxis regimen.

†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.¹

IQR=interquartile range
LEOPOLD=Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease

LEOPOLD Kids Trial: Main Study Pharmacokinetic (PK) Parameters

The PK parameters of KOVALTRY were investigated in 20 previously treated patients, 0 to <12 years of age, with severe Hemophilia A following administration of 50 IU/kg of KOVALTRY¹

Results expressed as arithmetic mean ± SD

AUC: area under the curve

C_max: maximum drug concentration in plasma after single dose

t_½: terminal half-life

CL: clearance

aOnly Chromogenic Substrate Assay was used for PK parameter assessment in LEOPOLD Kids.

bn=5

cOne subject considered PK outlier was excluded.

Results expressed as arithmetic median (Q1; Q3)

A graphic illustrating arithmetic median results that 89.7% of bleeding episodes resolved with <2 infusions of Kovaltry

LEOPOLD=Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease

LEOPOLD Kids Clinical Trial: Main and Extension Study

During the LEOPOLD Kids Main Study (N=51) and Extension Study (N=46), KOVALTRY demonstrated safety across patients aged 0 to <12 years^1,3†

Incidence of drug-related AE/SAEs in the Main Study period¹

Drug-related AEs: 2.0%; Drug-related SAEs: 0.0%

Incidence of drug-related AE/SAEs in the Extension Study period³

Drug-related AEs: 2.2%; Drug-related SAEs: 2.2%

Zero patients discontinued Kovaltry due to AE/SAEs^1,3

Most common (≥5%) adverse events were:^1,3

Inhibitors in previously untreated patients (PUPs)/minimally treated patients (MTPs)

Pyrexia, headache and rash

During the extension study (including measurements at 50-75 exposure days and ≥100 exposure days), no patients developed a new FVIII inhibitor³

†The extension period starts after the final visit in the main study and ends with the final visit in extension study.

LEOPOLD=Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease

Download the KOVALTRY LEOPOLD Brochure

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Review KOVALTRY LEOPOLD I Study Data

INDICATION FOR KOVALTRY®

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:

On-demand treatment and control of bleeding episodes

Perioperative management of bleeding

Routine prophylaxis to reduce the frequency of bleeding episodes

KOVALTRY is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

KOVALTRY is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins.

Hypersensitivity reactions, including anaphylaxis, are possible with KOVALTRY. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. Discontinue KOVALTRY if symptoms occur and seek immediate emergency treatment.

KOVALTRY may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.

Neutralizing antibody (inhibitor) formation has occurred following administration of KOVALTRY. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all Factor VIII products. Carefully monitor patients for the development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose, suspect the presence of an inhibitor.

Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII.

Catheter-related infections may occur when KOVALTRY is administered via central venous access devices (CVADs). These infections have not been associated with the product itself.

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.

For additional important risk and use information, please see full Prescribing Information.

References: 1. KOVALTRY [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2021. 2. Ljung R, Kenet G, Mancuso ME, et al. BAY 81-8973 safety and efficacy for prophylaxis and treatment of bleeds in previously treated children with severe hemophilia A: results of the LEOPOLD Kids Trial [published online December 9, 2015]. Haemophilia. doi:10.1111/hae.12866. 3. Bayer Data on File, April 2024. LEOPOLD Kids Extension. BAY 81-8973. 13400 Extension. Clinical Study Report, PH-41325.