SEVENFACT efficacy and safety

The efficacy and safety of SEVENFACT were demonstrated in the PERSEPT 1 clinical trial1,2

PERSEPT 1 Clinical Trial—efficacy and safety studied for the treatment and control of bleeding episodes in subjects with mild, moderate, or severe hemophilia A or B with inhibitors1,2

Prospective, randomized, open-label, crossover study of two initial dose regimens (IDRs) in 27 subjects ≥12 years old (range 12-54) with hemophilia A or B with inhibitors who experienced 468 bleeding episodes over the course of the study period*1,2

*PERSEPT=Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trial

†225 μg/kg initial dose regimen in the clinical trial.
‡75 μg/kg initial dose regimen in the clinical trial.
§Three of the 468 bleeds were considered severe life- and limb-threatening and were not included in this primary analysis.2

Study treatment protocol for mild or moderate bleeding episodes

Subjects averaged about 13 bleeds in six months prior to study entry2

A variety of bleeds were studied in the clinical trial2

~30% of bleeds were in target joints2

Bleeds included: knee, elbow/ankle, foot, shoulder, wrist/hand, hip, nose, mouth, and soft tissue/muscle2

Primary efficacy endpoint: The successful treatment of a mild or moderate bleeding episode 12 hours after initial SEVENFACT dose administration1

The primary efficacy endpoint included all of the following1:

— Subject assessment of “Good” or “Excellent” response using a 4-point hemostatic efficacy scale at 12 hours

— No further treatment with SEVENFACT or blood products at or beyond 12 hours

— No administration of other hemostatic treatments

— No increase in pain beyond 12 hours

Successful treatment—Bleeds had to achieve hemostatic efficacy at 12 hours, with no subsequent increase in pain, and not require additional SEVENFACT or any alternative treatment prior to 24 hours

SEVENFACT 225||:
Rapid, predictable, and reliable bleed control2

||225 μg/kg initial dose, followed, if necessary, 9 hours later by a 75 μg/kg dose every 3 hours until bleed control or 24-hour timepoint. Consider alternative treatments if successful control of bleeding does not occur within 24 hours of the first administration of SEVENFACT1

Rapid effect: 3 hour

At 3 hours, 84% of mild/moderate bleeding episodes were controlled with a single dose¶2

Predictable response: 84%

At 9 hours, 84% of mild/moderate bleeding episodes treated achieved bleed control after a single dose2

Reliable control: 99.5%

At 24 hours, 99.5% of mild/moderate bleeding episodes were resolved2
— At 12 hours, treatment with SEVENFACT 225 IDR had a higher success proportion than with SEVENFACT 75 IDR1

Convenient home use: 98%

98% of bleeding episodes were treated at home1

Success proportion that includes data from 158/213 bleeding episodes (excludes missing data).

SEVENFACT 75**: Confidence in clinical hemostasis

The majority of bleeding episodes were successfully treated at 12 hours1

**SEVENFACT 75: initial 75 μg/kg dose. Subsequently, a 75 μg/kg dose every 3 hours as needed until bleed control or 24-hour timepoint. Consider alternative treatments if successful control of bleeding does not occur within 24 hours of the first administration of SEVENFACT1

96.7% of mild/moderate bleeding episodes treated with SEVENFACT 75 were resolved at 24 hours2

98% of bleeding episodes were
treated at home1

Demonstrated safety profile1

In a clinical trial of SEVENFACT with 27 subjects and 468 bleeding episodes, both initial dose regimens were well tolerated.1,2

Subjects with a history of thromboembolic events were excluded from the trial. Serious arterial and venous thrombotic reactions can occur with SEVENFACT. Neutralizing antibodies may occur with SEVENFACT.1

Adverse reactions in SEVENFACT clinical trials (N=42)††1

Adverse reaction

Number

Infusion-site discomfort

4

Infusion-site hematoma

2

Dizziness

2

Infusion-related reaction

1

Headache

1

Increased body temperature

1

††In PERSEPT 1 and Phase 1b.

In the PERSEPT 1 clinical trial of 27 subjects1

No neutralizing antibodies

No allergic reactions

No thromboembolic events

  • Serious arterial and venous thrombotic reactions can occur with SEVENFACT

Hypersensitivity reactions1

Hypersensitivity reactions, including anaphylaxis, are possible with SEVENFACT, though none have been reported

People with known IgE-based hypersensitivity to rabbit proteins or casein may be at higher risk of hypersensitivity reactions

No immunogenic reactions related to SEVENFACT were reported; however, neutralizing antibodies may occur with the use of SEVENFACT.1

No thromboembolic events were reported; people with a history of thromboembolic events were excluded from the trials. Serious arterial and venous thrombotic reactions can occur with SEVENFACT.1

Manufactured to high quality and purity for your patients’ safety and peace of mind

SEVENFACT is a recombinant treatment for inhibitors and is not derived from human blood1

Goes through an extensive purification process before final production

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References:

  1. SEVENFACT [Prescribing Information]. HEMA Biologics; 2022.
  2. Data on file. HEMA Biologics.