IDELVION EFFICACY DATA IN PROPHYLAXIS AND ON-DEMAND

PHASE III PIVOTAL TRIALS

PROPHYLAXIS (ADULTS & ADOLESCENTS)

Phase III pivotal studies prove IDELVION has powerful efficacy with both 7- and 14-day dosing

ON 7- AND 14-DAY PROPHYLAXIS*

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 Information 9 AM–5 PM at 1-800-504-5434 or email medianfona@cslbehring.com.

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

*Data 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.

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.

Tony on ankle replacement surgery and IDELVION

Before my surgery we discussed the right IDELVION dosage options. Doing what I could to control the outcome and improve results felt good.

Watch Tony’s full story
20% trough levels with prophylactic use

IDELVION delivers high Factor IX trough levels at steady state on 7-day dosing4

LEARN MORE ABOUT STEADY-STATE FACTOR IX LEVELS
Up to 14-day dosing

Dosing schedules that meet your patients' needs

VIEW FULL DOSING INFORMATION

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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