IDELVION EFFICACY DATA IN PROPHYLAXIS AND ON-DEMAND

PHASE III PIVOTAL TRIALS

PROPHYLAXIS (ADULTS & ADOLESCENTS)

Patients who started and stayed on prophylaxis prove IDELVION has powerful efficacy with both 7- and 14-day dosing*

zero spontaneous bleeds
zero joint bleeds

EXTENSION STUDY

PROPHYLAXIS (ADULTS & ADOLESCENTS)

Long-lasting efficacy—evaluated up to 4 years in the phase III extension study2

Median AsBR – 0 IQR (0, 1.67) 7-day dosing (n=21), 0.37 IQR (0,1.68) 14-day dosing (n=40)
Median AjBR – 0.8 IQR (0,2.34) 7-day dosing (n=21), 0.13 IQR (0, 2.34) 14-day dosing (n=40)

For information on pediatric patient data, call CSL Behring Medical Information at 1-800-504-5434 or email MedInfoNA@cslbehring.com.

 Abbreviations: AjBR, annualized joint bleeding rate; AsBR, annualized spontaneous bleeding rate; IQR, interquartile range.

 *Of the 23 subjects in Arm 2, 19 were transitioned from on-demand to 7-day prophylaxis. The median AsBR during prophylaxis treatment was 0.7 (range: 0 to 4.2). Data for Arms 1 and 2 based on matched-pairs design.

 †IQR is the middle 50% of people in a clinical study.

Phase II/III study design: The safety and efficacy of IDELVION were evaluated in a prospective, open-label, multicenter clinical study of 63 male PTPs with hemophilia B (≤2% endogenous FIX activity) who received at least one infusion of IDELVION. Subjects were aged 12 to 61 years; including 7 adolescent subjects aged 12 to 17. Subjects were treated for up to 27 months.

Phase III extension study design: This multicenter, open-label phase III extension study investigated the long-term safety and efficacy of IDELVION for routine prophylaxis and on-demand treatment of bleeds. Hemophilia B PTPs (FIX ≤2%) (n=59) who participated in a phase III pivotal study or who underwent surgery with IDELVION and continued with prophylaxis were enrolled in the study. Enrolled subjects were males aged 13–63 (mean age: 36.1 years). Five subjects were between 12–17 years of age. During the study, subjects were treated for a median (range) of 36.8 (7, 49) months. The primary endpoint of the extension study was the total number of subjects who develop inhibitors against FIX.

ON-DEMAND USE
PERIOPERATIVE EFFICACY

IDELVION resolved a majority of bleeds with a single on-demand infusion

95% of bleeds resolved with 1 infusion image
99% of bleeds resolved with 1-2 infusions image

‡In patients not receiving prophylaxis.

IDELVION demonstrated powerful hemostasis in surgery

93% of rated surgeries were excellent or good for hemostatic efficacy3
97% of surgeries needed just 1 preoperative dose to maintain hemostasis3

PROLONG-9FP surgical substudy design: This study enrolled male patients, ≤65 years old with severe hemophilia B (FIX activity ≤2%) requiring non-emergency surgery. A total of 30 surgeries have been conducted in 21 patients, including four surgeries in four pediatric patients.

20% trough levels with prophylactic use

High and sustained Factor IX levels in clinical trials

LEARN MORE ABOUT STEADY-STATE FACTOR IX LEVELS
7- And 14-day dosing 7- And 14-day dosing

Two dosing schedules that meet your patient's individual needs

VIEW FULL DOSING INFORMATION

  §Once well‑controlled (1 month without spontaneous bleeding or requiring dose adjustments on a weekly dose of ≤40 IU/kg), people 12 years and older can be transitioned to 14-day dosing.

  §Once well-controlled (1 month without spontaneous bleeding or requiring dose adjustments on a weekly dose of ≤40 IU/kg), people 12 years and older can be transitioned to 14-day dosing.

References: 1. 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. 2. Mancuso ME, Pan-Petesch B, Lissitchkov T, et al. Long-term safety and efficacy of rIX-FP prophylaxis with extended dosing intervals up to 21 days in adults/adolescents with hemophilia B. J Thromb Haemost. In press. 3. Curtin J, Santagostino E, Karim FA, Li Y, Seifert W, Négrier C. Simplifying surgery in haemophilia B: Low factor IX consumption and infrequent infusions in surgical procedures with rIX-FP. Thromb Res. 2020;188:85-89. 4. 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.

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