Prophylaxis: Median annualized spontaneous bleeding rate (AsBR) of zero

  • In the clinical trials, 21 subjects were transitioned from 7-day to 14-day prophylaxis. The median AsBRs 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


On-demand: 99% of bleeds controlled with 1-2 infusions

99% of bleeds controlled with 1-2 infusions of IDELVION | 94% of bleeds controlled with 1 infusion of IDELVION

Perioperative management: Excellent hemostatic response

of rated surgeries were excellent or good for hemostatic efficacy

In three clinical studies, 13 subjects received IDELVION for perioperative management of 15 surgical procedures. The 15 surgical procedures included a double mastectomy, four knee replacements, a hemorrhoidectomy, a rhinoplasty, a nevus excision, an ankle arthroplasty, an endoscopic mucosal resection, four complicated dental surgeries and one uncomplicated dental surgery. Two of the four dental surgeries were performed in children <12 years of age.

Albumin fusion technology extends half-life in IDELVION

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


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

Dosing schedule that meets your patients' needs


‡In appropriate patients 12 years and older.

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