Recombinant factor IX-albumin fusion protein (rIX-FP) provides effective hemostasis at dose regimens for up to 21 days in patients with hemophilia B aged ≥18 years and up to 14 days in patients aged <12 years, according to real-world data published in the Journal of Clinical Medicine.
Moreover, rIX-FP has a favorable pharmacokinetic profile and excellent safety and tolerability profile based on the findings of the PROLONG-9FP clinical program. Extended dosing intervals led to high levels of adherence and reduced consumption compared to other factor IX replacement therapies, with potential economic benefit.
“Data from real-world practice are encouraging and reflect the results of the clinical trials,” the authors wrote. rIX-FP is a long-acting factor IX replacement product for the prophylactic treatment of hemophilia B or the perioperative management of children and adults with the disease.
Read more about hemophilia therapies
Factor IX is the blood clotting factor that is deficient in patients with hemophilia B. Even though there are many factor IX replacement products, these can have a high treatment burden due to frequent dosing. Long-acting products can achieve bleed protection even with extended dosing intervals.
The PROLONG-9FP clinical trial program consisted of 5 prospective, open-label, multicenter studies that assessed the safety, efficacy, and pharmacokinetics of rIX-FP in male patients with moderately severe to severe hemophilia B. The trials also included the assessment of extended dosing regimens, management of surgical bleeding, and analysis of long-term outcomes.
The favorable efficacy and consumption of rIX-FP over standard factor IX products and other long-acting products “provide a basis for switching patients to rIX-FP,” the authors said. Extended intervals between rIX-FP doses and lower doses may be tested in future studies to improve individual patients’ options, they said.
Escobar M, Mancuso ME, Hermans C, et al. Idelvion: a comprehensive review of clinical trial and real-world data. J Clin Med. 2022;11(4):1071. doi:10.3390/jcm11041071