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)
IDELVION uses albumin fusion technology to extend half‑life with minimal risk of an immune response
SEE THE IDELVION MOA*The median AsBR for patients who started and stayed on 7- or 14-day prophylaxis was 0. For patients who switched to prophylaxis from on-demand, the median AsBR was 0.7.
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.