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Patients 12 years and older

Pivotal study design in patients 12 years and older

The pivotal phase II/III, multicenter, open-label, nonrandomized study (N=137) evaluated the efficacy, PK, and safety of ADYNOVATE® twice-weekly prophylaxis vs on-demand treatment, and determined hemostatic efficacy in the treatment of bleeding episodes for 6 months.1

The primary endpoint was to compare the ABR between the prophylactic and on-demand treatment regimens.3

Prophylaxis (40-50 IU/kg, twice-weekly) vs on-demand (10-60 IU/kg) treatment1,3

Pivotal study design in patients 12 years and older

ABR=annualized bleed rate.

*Treated population=subjects assigned to routine prophylaxis or on-demand treatment with ADYNOVATE and who received at least one dose of the product.

†N=120 in the prophylaxis-arm treated population; one patient received ADVATE® [Antihemophilic Factor (Recombinant)] during initial PK analysis, and was assigned to ADYNOVATE prophylaxis, but did not receive any ADYNOVATE treatment.

‡Per-protocol population=all subjects who were assigned to the prophylactic or the on-demand treatment regimen, treated with their originally assigned dose for the entire duration of study participation and who fulfilled the protocol compliance requirements.

Proven prophylaxis in children and adults (12 years and older)

In the 6-month clinical study: reduction in bleeds when switched from on-demand to prophylaxis.1

95% reduction in median overall ABR on-demand vs prophylaxis

Striving toward a goal of zero bleeds with ADYNOVATE® prophylaxis

During the 6-month clinical study in children and adults (12 years and older) receiving twice-weekly prophylaxis treatment1:

Zero median ABR for joint and spontaneous

ABR=annualized bleed rate; IQR=interquartile range.

Prophylaxis helped some patients stay bleed-free

During the 6-month study in children and adults (12 years and older)1:

Prophylaxis helped some patients stay bleed-free

Effective bleed control in children and adults (12 years and older)

When bleeds did occur in either study arm, the majority were controlled with a single infusion of ADYNOVATE®.1

In the clinical trial, bleeding episodes controlled:

96.2% of all bleeding episodes controlled with 1 or 2 infusions

*Excellent defined as full relief of pain and objective signs of bleeding cessation; Good defined as definite pain relief and/or improvement in signs of bleeding.1

Designed to extend FVIII circulation time

In the adolescent and adult (12 years and older) pivotal study, a PK comparison of ADYNOVATE® vs ADVATE® [Antihemophilic Factor (Recombinant)] was conducted in 26 subjects prior to initiation of prophylactic treatment with ADYNOVATE.5

The extended terminal half-life of ADYNOVATE was 1.4X–1.5X longer than that of ADVATE (based on one-stage clotting and chromogenic assay, respectively).5

Chart showing ADYNOVATE clinical study results Chart showing ADYNOVATE clinical study results

PEGylation Technology* was deliberately chosen because

  • It allows for half-life extension while maintaining the integrity of the ADVATE protein5,6
  • It has a long history of use as an extension technology7

*Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.

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Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

SELECTED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).


WARNING & PRECAUTIONS

Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to reduce the frequency of bleeding episodes

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

SELECTED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).


WARNING & PRECAUTIONS

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to reduce the frequency of bleeding episodes

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

DETAILED IMPORTANT RISK INFORMATION

Click here for ADYNOVATE Prescribing Information.



ADVATE [Antihemophilic Factor (Recombinant)] Important Information
Indications

ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • Control and prevention of bleeding episodes.
  • Perioperative management.
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

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

DETAILED IMPORTANT RISK INFORMATION

Neutralizing Antibodies
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

  • Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
  • The most common adverse reactions observed in clinical trials (>% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.

Click here for ADVATE Prescribing Information.