Features and properties of efanesoctocog alfa

Alternative names	ALTUVIIIO; antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl; BIVV-001; Factor VIII recombinant—Bioverativ/Sanofi; Fc-VWF-XTEN fusion protein-ehtl; rFVIIIFc-VWF-XTEN
Class	Antihemorrhagics, Blood coagulation factors, Recombinant fusion proteins
Mechanism of action	Factor VIII replacement Fc, VWF, and XTEN portions of the molecule extend plasma t1/2 Mean t1/2 is up to 4 x longer than with rFVIII and mean AUC is up to 7 x higher
Route of administration	Intravenous
Pharmacodynamics	Similar dose-dependent efficacy to rFVIII in vitro in hemophilia A whole blood/plasma for whole blood clotting time, peak thrombin generation, endogenous thrombin potential, promotion of fibrin clot formation, and clot stability in the presence of tissue plasminogen activator Similar dose-dependent acute hemostatic activity and 24h survival rates to rFVIII after equivalent doses in hemophilia A mouse models of bleeding No correlation between t1/2 or CL and VWF antigen levels in patients with severe hemophilia A
Pharmacokinetics (steady state)	Adults/adolescents: mean t1/2 47.0 h, maximum FVIII activity 151 IU/dL, mean AUCτ 11,500 IU·h/dL, mean CL 0.439 mL/h/kg, mean incremental recovery 3.00 IU/dL per IU/kg; FVIII activity > 40 IU/dL for a mean 4.1 days after administration and 15.2 IU/dL at day 7. Children: FVIII activity > 40 IU/dL for 2–3 days after administration and > 5 IU/dL at day 7
Adverse events
Most frequent (incidence >10%)	Headache, arthralgia
ATC codes
WHO ATC code	B02B-D02 (Coagulation Factor VIII)
EphMRA ATC code	B2D (Blood Coagulation)