Indication

IDELVION: A factor for freedom

  • Delivers high* and sustained FIX levels2
  • Effective prevention and control of bleeding episodes in adults and children3,4
  • Effective in perioperative management5

*FIX levels above 5% for 14 days at 75 IU/Kg.

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

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

Technology

IDELVION uses albumin fusion technology to extend half-life6

Recombinant Albumin
Albumin, known for its long half-life and low risk for immunogenic reaction, is fused with rFIX to form IDELVION7
rFIX
IDELVION remains intact in the bloodstream until FIX is activated6
Cleavable Peptide Linker
A cleavable peptide linker helps maintain the normal function of FIX, releasing FIX only when needed for coagulation7

Efficacy

IDELVION delivers high and sustained FIX levels providing patients with protection from bleeds2

Linear plot of baseline-corrected FIX activity. Graph adapted from Santagostino et al, 2012.2

Efficacy as prophylaxis

Prophylaxis: Median annualised spontaneous bleeding rate (AsBR*) of zero

The median AsBR* for subjects that received the 7- or 14-day prophylactic treatment in the clinical trial was zero.3

*See glossary of terms.

  • Significant reduction in AsBR* when patients switched from on-demand regimen to weekly prophylaxis (p <0.0001)3
  • Similar results were observed in the phase III paediatric trial (patients <12 years of age)4
  • Median AsBR was 0.00 and was similar between those <6 years old and those ≥6 years old4

*See glossary of terms.

*Based on matched-pairs design. Subjects evaluable for efficacy received at least 1 dose of on-demand treatment and 1 dose of prophylactic treatment.

Graph adapted from Santagostino et al, 2016.3

Efficacy as on demand

IDELVION provides rapid and complete control of bleeding episodes3

Efficacy in surgery

Effective in perioperative management across 21 surgeries5

  • 21 major and minor surgeries performed in 19 patients including 9 major orthopaedic surgeries5
  • In 20/21 surgeries, a single perioperative dose maintained intraoperative haemostasis5

Efficacy in children

Effective prevention and control of bleeds in children4

  • 97.2% of bleeding episodes treated with 1 or 2 injections4
  • – 88.7% treated with 1 injection4
  • 96% of treatments rated as ‘excellent’ or ‘good’ for efficacy4
  • Majority of bleeding episodes were due to trauma4

FIX activity after injection of a single dose of IDELVION or previous FIX product (PK population). Mean baseline-uncorrected FIX activity after administration of a single injection of 50 IU/kg of IDELVION or 50 IU/kg previous FIX product (pdFIX or rFIX). Graph adapted from Kenet et al., 2016.4