HIGH FACTOR IX TROUGH LEVELS AT STEADY STATE
IDELVION gives patients powerful and sustained protection
“It's the peace of mind I get having high factor levels; especially in my day-to-day life.”
High factor levels give this police officer the bleed protection he needs to do the job he loves
IDELVION sustained high FIX trough levels with 7-day prophylaxis in patients ≥12 years in clinical trials
IDELVION sustained high FIX trough levels with 14-day prophylaxis in patients ≥12 years in clinical trials
*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
EXTENDED HALF-LIFE EXTENDED TIME BETWEEN DOSES
In the pivotal trial, IDELVION delivered a prolonged half-life.- In clinical trials, previous FIX products had an average half-life of 22 hours.3 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 sustained high FIX levels with 7-day prophylaxis in patients <12 years in clinical trials
*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 with a single dose in patients <12 years
- 7 days above 9% with a single dose of 50 IU/kg
Zero median annualized spontaneous bleeding rate (AsBR) when dosed at 7 or 14 days in clinical trials
IDELVION uses albumin fusion technology to extend half-life with minimal risk of an immune response
References: 1. Data on file. Available from CSL Behring as DOF IDL-002. 2. Santagostino E, Martinowitz U, Lissitchkov T, et al. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial. Blood. 2016;127(14):1761-1769.
3. Data on file. Available from CSL Behring as DOF IDL-001. 4. Santagostino E, Negrier C, Klamroth R, et al. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood. doi:10.1182/blood-2012-05-429688.
Reference: 1. Data on file. Available from CSL Behring as DOF IDL-002.