IDELVION PROVIDES LONG‑LASTING PROTECTION

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

7- and 14-DAY PROPHYLAXIS*

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

100%
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

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

‡In appropriate patients 12 years and older.

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