Indication

IDELVION is indicated for the prophylaxis and treatment of bleeding in patients with haemophilia B (congenital factor IX deficiency) including treatment and prevention of bleeding in surgical settings.1

Please refer to the SPC for full details on any special warnings and precautions for use.

IDELVION

  • Demonstrates FIX levels above 5% for 14 days at 75 IU/kg providing patients ≥12 years with protection from bleeding episodes.2
  • Demonstrates mean steady-state FIX trough level of 7.6% in patients >18 years when administered every 21 days at a median dose of 100 IU/kg.3
  • Effective prevention and treatment of bleeding episodes in adults and children.4,5
  • Effective in perioperative management.6

Technology

IDELVION uses albumin fusion technology to extend half-life7

GBR-IDL-0138
Date of preparation: June 2021
Recombinant Albumin
Albumin, known for its long half-life and low risk for immunogenic reaction, is fused with rFIX to form IDELVION8
rFIX
IDELVION remains intact in the bloodstream until FIX is activated7
Cleavable Peptide Linker
A cleavable peptide linker helps maintain the normal function of FIX, releasing FIX only when needed for coagulation8

Efficacy

Demonstrates FIX levels above 5% for 14 days at 75 IU/kg providing patients ≥12 years with protection from bleeding episodes2

Efficacy as prophylaxis

In the phase 3 registration study, the median AsBR was zero both for subjects ≥12 years receiving 7-day (n=21, IQR 0.00-0.00) and 14-day (n=21, IQR 0.00-1.00) prophylactic treatment (within subject comparison).4

In the phase 3b extension study, the median AsBR was zero both of subjects ≥12 years receiving 7-day (n=21, IQR 0.00-1.67) and >18 years receiving 21-day (n=11, IQR 0.00-0.45) prophylactic treatment. For subjects ≥12 years receiving 14-day prophylactic treatment, the median AsBR was 0.37 (n=40, IQR 0.00-1.68).

  • Median AsBR of zero for patients ≥12 years receiving 7- or 14-day prophylactic treatment regimens in the phase 3 clinical study.4
  • Significant reduction in AsBR when IDELVION patients switched from on-demand regimen to weekly prophylaxis (p<0.0001).4

Efficacy as on demand

IDELVION provides control of bleeding episodes in patients ≥12 years.3,4

In the phase 3b extension study, overall, 90.1% and 96.5% of bleeding episodes were successfully treated with 1 or 2 IDELVION infusions.**3(n=38)

**Based on 38 patients who experienced bleeding episodes requiring treatment with IDELVION. 317/328 bleeding episodes were treated with 1 or 2 injections. 

Efficacy in surgery

Effective in perioperative management across 30 surgeries (n=21)6

  • 30 major and minor surgeries performed in 21 patients including 15 major joint replacement surgeries.6
  • Haemostatic efficacy rated as ‘good’ or ‘excellent’ in 87.5% (7/8) of minor surgeries and 95.5% (21/22) of major surgeries.6

Efficacy in children

Effective prevention and control of bleeds in patients <12 years receiving once-weekly IDELVION (n=27) in the phase 3 paediatric registration study5

  • 97.2% of bleeding episodes treated with 1 or 2 injections.*5
  • – 88.7% treated with 1 injection.5
  • 96% of treatments rated as ‘excellent’ or ‘good’ for efficacy.5
  • Majority of bleeding episodes (69%) in the phase 3 clinical study were due to trauma.5 

*Based on 23 patients who experienced bleeding episodes requiring treatment. 103/106 bleeding episodes were treated successfully with 1 or 2 injections.