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Read Important Information on Helixate® FS, Antihemophilic Factor (Recombinant)

Read Important Information on Helixate® FS, Antihemophilic Factor (Recombinant)

AFSTYLA Delivers Long-lasting Protection From Bleeds

Zero bleeds (median AsBR*) on prophylaxis regimen

All patients
Patients 12 Years
Patients <12 Years
ZERO BLEEDS (median annualized spontaneous bleeding rate) all patients
ZERO BLEEDS (median annualized spontaneous bleeding rate) patients ≥12
ZERO BLEEDS (median annualized spontaneous bleeding rate) patients <12

Proven efficacy under real-world conditions

AFSTYLA was tested in the largest hemophilia A pivotal clinical trial program to date, with 258 previously treated patients with severe hemophilia A (226 received prophylaxis).

  • Physicians in the study had the freedom to determine each patient’s optimal dosing regimen
    • 85% of patients were dosed 2x or 3x weekly (39% were dosed 2x weekly and 46% were dosed 3x weekly)
  • AFSTYLA delivered zero median AsBR in all studied populations regardless of dosing regimen
    • Results were comparable in patients dosed 2x or 3x weekly
Pediatric Hemophilia A patient image
*Annualized spontaneous bleeding rate in clinical trials (IQR=0–2.4 for patients ≥12 years; 0–2.2 for patients <12 years). Annualized bleeding rate in clinical trials (IQR=0–4.2 for patients ≥12 years; 0–7.2 for patients <12 years).

Study design

Data from two AFSTYLA studies

Phase I/III, open-label, multicenter, crossover study in patients ≥12 years, and a phase III open-label, multicenter study in patients <12 years.

Adult/adolescent study

175 previously treated male patients with severe hemophilia A (<1% endogenous Factor VIII activity) ages 12 to 65 years, including 14 adolescent patients 12 to 18 years. 174 patients received at least one dose of AFSTYLA and 173 (99%) were evaluable for efficacy. A total of 161 patients (92.5%) completed the study.

Pediatric study

84 previously treated male children (35 patients 0 to <6 years and 49 patients ≥6 to <12 years) with severe hemophilia A (<1% endogenous Factor VIII activity). Of the 84 enrolled patients, all received at least one dose of AFSTYLA and 83 (99%) were evaluable for efficacy.

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