IDELVION PROVIDES LONG-LASTING PROTECTION

PROPHYLAXIS: Only IDELVION offers powerful bleed protection and is FDA approved for up to 14-day dosing

  • In the clinical trials, 21 subjects were transitioned from 7-day to 14-day prophylaxis. The median annualized spontaneous bleeding rates (AsBR) for each dose were zero and zero, respectively
  • When dosed every 7 days, interquartile range (IQR)* was 0.0–0.0 bleeds
  • When dosed every 14 days, IQR was 0.0–1.0 bleeds

*IQR is the middle 50% of people in a clinical study and is used as a more accurate measure
  of expected range.

Data based on a matched-pairs design.

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 additional median duration of 10 months.

ZERO BLEEDS in prophylaxis in clinical trials

7- and 14-DAY PROPHYLAXIS

ON-DEMAND: IDELVION achieves high trough levels for more than 2 weeks with a single dose in patients ≥12 years

Table showing data for baseline-corrected mean FIX activity in patients ≥12 years

A majority of bleeds resolved within 1–2 infusions:

  • 94% of bleeds resolved with 1 infusion
  • 99% of bleeds resolved within 1–2

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.1

PERIOPERATIVE MANAGEMENT: IDELVION has excellent hemostatic response in surgery

100% of rated surgeries were excellent or good for hemostatic efficacy with IDELVION

of rated surgeries were excellent or good for hemostatic efficacy

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


Patient population included:

  • 10 previously treated patients (PTPs) between 12 and 61 years of age
  • 3 surgical procedures in 3 children ≤12 years old

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

Tony recovered from ankle replacement surgery while on IDELVION

Albumin fusion technology extends half-life in IDELVION

IDELVION uses albumin fusion technology to extend half-life with minimal risk for an immune response

SEE THE IDELVION MOA

IDELVION is the only recombinant FIX therapy with up to 14-day dosing

Dosing schedule that meets your patients' needs

VIEW FULL DOSING INFORMATION

Reference: 1. 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. doi:10.1182/blood-2012-05-429688.

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