HIGH STEADY-STATE FACTOR LEVELS WITH CONTINUED USE

Adult
Pediatric

IDELVION sustained high FIX levels with 7-day prophylaxis in patients ≥12 years in clinical trials

Table showing data for adult steady state mean FIX activity—21% when dosed every 7 days

IDELVION sustained high FIX levels with 14-day prophylaxis in patients ≥12 years in clinical trials

Table showing data for adult steady state mean FIX activity—13% when dosed every 14 days

* Steady-state levels measured FIX at trough levels before each infusion every four weeks until week 92 at 7-day prophylaxis and week 104 at 14-day prophylaxis. Mean calculated from the entire length of study. For the duration of the phase III study, mean FIX activity was 20.0% with 7-day dosing, while mean FIX activity was 12.4% with 14-day dosing.2


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

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BASELINE-CORRECTED MEAN FIX ACTIVITY IN PATIENTS ≥12 YEARS3,‡§
legend
  • 14 days above 5% with a single dose of 75 IU/kg

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.3


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IDELVION sustained high FIX levels with 7-day prophylaxis in patients <12 years in clinical trials

Table showing data for pediatric steady state mean FIX activity—14% when dosed every 7 days

*Steady-state levels measured FIX at trough levels before each infusion at weeks 4, 12, 24, and 36 at 7-day prophylaxis.
†Mean calculated from the entire length of study.


IDELVION achieves high trough levels for 1 week with a single dose in patients <12 years

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Table showing data for pediatric steady state mean FIX activity in patient <12 years
  • 7 days above 9% with a single dose of 50 IU/kg

Extended half-life.
Extended Time
Between doses.

In the pivotal trial, IDELVION delivered a prolonged half-life.
  • In clinical trials, previous FIX product had a half-life of 22 hours. Previous FIX products refer to plasma-derived or recombinant FIX4
  • Half-life is based on a single dose of 50 IU/kg in adults (≥18 years)
IDELVION provides a half-life of 104 hours
ZERO BLEEDS in prophylaxis with IDELVION in clinical trials

Zero median annualized spontaneous bleeding rate (AsBR) when dosed at 7 or 14 days in clinical trials

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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

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