Adult & Adolescent Study - Pharmacokinetics

Only ALTUVIIIO provided Factor VIII activity levels in the normal to near-normal (>40%) range for most of the week in the Phase 1 study of adults¹

Phase 1 sequential PK study²

* Data from a Phase 1 trial in 13 previously treated adults with severe hemophilia A. Pharmacokinetic profiles of ALTUVIIIO, Advate^® [Antihemophilic Factor (Recombinant)], and Adynovate^® [Antihemophilic Factor (Recombinant), PEGylated] were evaluated after sequential IV infusions. Primary objective: assess the elimination half-life for each product. Secondary objectives: characterization of additional PK parameters; evaluation of safety and tolerability of ALTUVIIIO.³
† Lower interpatient variability assessed across PK parameters (AUC, half-life, clearance) was also seen in XTEND-1.⁴
Advate and Adynovate are registered trademarks of Baxalta Incorporated, a Takeda company.

Normal to near-normal Factor VIII activity levels for most of the week were also seen in the Phase 3 XTEND-1 trial⁴*

Phase 3 XTEND-1 sequential PK subgroup (n=17)⁴

XTEND-1 trial adult study population (n=125)¹

Once-weekly ALTUVIIIO provided


• ~4 days with mean Factor VIII levels above 40% (normal to near-normal range)¹
• Factor VIII trough levels of 18.0%^1†
  • Factor VIII clearance has been demonstrated to be higher in patients <18 years, resulting in lower trough levels¹

The pharmacokinetic profile was similar after the first dose and after 26 weeks of weekly dosing. A steady state was achieved after the first dose of ALTUVIIIO.¹

* Data from the Phase 3 XTEND-1 study in 134 adults (≥18 years) receiving a weekly IV infusion of 50 IU/kg ALTUVIIIO. PK parameters shown are based on plasma Factor VIII activity measured by the aPTT-based one-stage clotting assay.¹
† Mean trough level was computed using available measurements at Week 52/end of study PK sampling visit for the adult population in the XTEND-1 study (n=123).¹