KOVALTRY Efficacy & Safety: Adolescents & Adults

LEOPOLD I Clinical Trial: Main Study

Proven efficacy and safety in adolescents and adults with prophylaxis using as few as 2 infusions per week¹

ABR by Dosing Regimen¹

Dosing was determined by investigators to meet individual patients' needs¹

Graphic displaying ABR for 2x/week and 3x/week prophylaxis with Kovaltry in adolescents and adults

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

IQR=interquartile range

LEOPOLD I Clinical Trial: Main Study Pharmacokinetics (PK) Parameters

The PK parameters of KOVALTRY were investigated in 26 previously treated adolescent and adult patients 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

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

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

LEOPOLD I Clinical Trial: Main and Extension Study

Adult LEOPOL I Clinical Trial Extension Study Table

Comparison of joint bleeds in Main and Extension study and median time to first bleed

*43 patients completed the extension study
LEOPOLD=Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease

During the LEOPOLD I Main Study (N=62) and Extension Study (N=55), KOVALTRY demonstrated safety across patients aged 12 and older^1,3†

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

Drug-related AEs: 6.5%; Drug-related SAEs: 0.0%

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

Drug-related AEs: 5.5%; Drug-related SAEs: 1.8%

In the extension study period, one patient discontinued Kovaltry due to an SAE^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 main and extension studies, no patient developed inhibitor antibodies to FVIII^1,3

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

‡There was 1 SAE, a myocardial infarction, in a patient with known risk factors for cardiovascular events. The investigator considered this event to be treatment related, but not related to the specific study drug. The patient recovered after 2 weeks on remedial drug therapy.

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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. Data on file. Bayer HealthCare Pharmaceuticals, Inc; 2016. 3. Bayer Data on File, April 2024. LEOPOLD I Extension. BAY 81-8973. 12594 Extension. Clinical Study Report Addendum 1, PH37225.