LONG-LASTING BLEED PROTECTION ACROSS DOSING REGIMENS

PROPHYLAXIS: The only extended half-life Factor IX therapy with zero spontaneous bleeds in adults and children

  • In the clinical trials, 21 subjects were transitioned from 7-day to 14-day prophylaxis. The median annualized spontaneous and joint bleeding rates for each dose were zero and zero, respectively
    • When dosed at 7 days, interquartile range (IQR) was 0.0–0.0 for spontaneous and joint bleeds
    • When dosed every 14 days, IQR was 0.0–1.0 for spontaneous bleeds and 0.0–1.04 for joint bleeds
Explore IDELVION Factor IX steady-state trough levels

7- and 14-day prophylaxis*

0 spontaneous bleeds and 0 joint bleeds in 7- and 14-day prophylaxis*

*Data based on matched-pairs design. IQR is the middle 50% of people in a clinical study.

Phase II/III study design: The safety and efficacy of IDELVION were evaluated in a prospective, open-label, multicenter clinical study of 63 male PTPs with hemophilia B (≤2% endogenous FIX activity) who received at least one infusion of IDELVION. Subjects were aged 12 to 61 years; including 7 adolescent subjects aged 12 to 17. Subjects were treated for up to 27 months. Forty subjects received weekly routine prophylaxis. Thirty-seven subjects completed 6 months of once-weekly prophylaxis. Of these, 21 subjects switched to a 14-day interval with 50–75 IU/kg of IDELVION. Twenty-three subjects received IDELVION only for the treatment of bleeding episodes during the first 6 months of the study. Nineteen switched to once-weekly prophylaxis with an additional median duration of 10 months.

ON-DEMAND: A majority of bleeds resolved with 1 infusion

94% of bleeds reolved with 1 infusion image
99% of bleeds reolved with 1-2 infusions image
IDELVION achieved high trough levels for more than 2 weeks with a single dose chart

After administration of a single infusion of IDELVION. § Data from the phase I trial, a first-in-human prospective, multicenter, open-label dose-escalation study to evaluate the safety and PK of 25, 50, and 75 IU/kg rIX-FP in subjects with hemophilia B. Twenty-five subjects were enrolled in order to ensure at least 13 evaluable subjects in the 50 IU/kg dosing group, and at least 4 evaluable subjects in both the 25 and 75 IU/kg rIX-FP dosing groups. All subjects received rIX-FP in a non-bleeding state and after a washout period of at least 4 days from their last dose of the previous FIX product.2

PERIOPERATIVE MANAGEMENT: IDELVION is proven effective in surgery

100% of rated surgeries were excellenet or good for hemostatic efficacy image

Patient population included:

  • 10 previously treated patients (PTPs) between 12 and 61 years of age
  • 3 surgical procedures in 3 children <12 years old
95% of surgeries needed just 1 preoperative dose to maintain hemostasis image

 In 3 clinical studies, 13 subjects received IDELVION for perioperative management of 15 surgical procedures.

Tony on ankle replacement surgery and IDELVION

Before my surgery we discussed the right IDELVION dosage options. Doing what I could to control the outcome and improve results felt good.

Watch Tony’s full story
20% trough levels with prophylactic use

IDELVION delivers high Factor IX trough levels at steady state—20% on 7‑day dosing and 13% on 14‑day dosing4

SEE IDELVION FIX LEVELS
Up to 14-day dosing (FDA approved)

Dosing schedule that meets your patients' needs

VIEW FULL DOSING INFORMATION

References: 1. Santagostino E, Martinowitz U, Lissitchkov T, et al. Long acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial. Blood. 2016;127(14):1761-1769. 2. Santagostino E, Negrier C, Klamroth R, et al. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood. 2012;120(12):2405-2411. 3. Négrier C, Karim FA, Lepatan LM, et al. Efficacy and safety of long-acting recombinant fusion protein linking factor IX with albumin in haemophilia B patients undergoing surgery. Haemophilia. 2016;22(4):e259-e266. 4. Gill JC, Roberts J, Li Y, Castaman G. Sustained high trough factor IX activity levels with continued use of rIX-FP in adult and paediatric patients with haemophilia B. Haemophilia. 2019. doi:10.1111/hae.13735.

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