IDELVION PROVIDES THE PROTECTION OF HIGH STEADY-STATE FACTOR IX TROUGH LEVELS
This elevated trough sustaining Factor IX therapy delivered 20% steady-state levels with 7-day dosing
Prolonged bleed protection with high steady-state Factor IX trough levels with 14-day dosing
*Only time points with ≥3 observations are plotted. Steady-state mean trough is calculated from all observations at any time point. The mean dose for patients receiving prophylaxis every 7 days was 37 IU/kg.
EXTENDED HALF‑LIFE. EXTENDED TIME BETWEEN DOSES.
In the pivotal trial, IDELVION delivered a prolonged half‑life
- In clinical trials, previous Factor IX products used by subjects had an average half-life of 22 hours. Previous Factor IX products refers to plasma-derived Factor IX or rFIX3
- Half‑life is based on a single dose of 50 IU/kg in adults (≥18 years)
Patients who started and stayed on prophylaxis prove IDELVION has powerful efficacy with both 7- and 14-day dosing†
VIEW EFFICACY DATA
IDELVION uses albumin fusion technology to extend half‑life with minimal risk of an immune response
SEE THE IDELVION MOA†Of the 23 subjects in Arm 2, 19 were transitioned from on-demand to 7-day prophylaxis. The median AsBR during prophylaxis treatment was 0.7 (range: 0 to 4.2). Data for Arms 1 and 2 based on matched-pairs design.
References: 1. 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. 2. Data on file. Available from CSL Behring as DOF IDL-003. 3. Data on file. Available from CSL Behring as DOF IDL-001.