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

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

IDELVION sustained high FIX trough 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


VIEW PEDIATRIC STEADY-STATE FIX TROUGH LEVELS

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 provides a half-life of 104 hours

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 with a single dose in patients <12 years

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

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

VIEW EFFICACY DATA

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

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.

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