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

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

Long-lasting Protection With a Twice-weekly Dosing Option for Prophylaxis

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

Cody turns to AFSTYLA for bleed protection

“As a paramedic...it's an active job. Being able to work and be protected by my factor product is huge."

–Cody switched to AFSTYLA

‡Testimonial is the speaker's personal experience. Individual results may vary.

Efficacy established in adults, adolescents, and children

AFSTYLA was tested in the largest FVIII 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
  • AFSTYLA delivered zero median AsBR in all studied populations
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). Median 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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