Drug intelligence / Profile preview

long-acting activated recombinant human factor VII

Development stage
Phase 1
Lead developer
Novo Nordisk
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

**Long-acting activated recombinant human factor VII** is an engineered form of **recombinant activated coagulation factor VII (rFVIIa)** designed for extended half-life or reduced dosing frequency compared to standard rFVIIa formulations. The protein is manufactured by recombinant DNA technology, with modifications intended to prolong its circulation time or enhance its pharmacokinetic properties. Mechanistically, activated recombinant human factor VII binds to exposed tissue factor at sites of vascular injury, forming a complex that activates factor IX to factor IXa and factor X to factor Xa. This cascade leads to initial thrombin generation, platelet activation, and formation of a haemostatic plug independent of factors VIII and IX, and at higher pharmacological doses can directly activate factor X on the surface of activated platelets. Clinical indications for rFVIIa include treatment and prophylaxis for bleeding episodes in congenital hemophilia A or B with inhibitors, acquired hemophilia, congenital factor VII deficiency, and Glanzmann thrombasthenia refractory to platelet transfusion. For long-acting rFVIIa, extension of dosing intervals is the intended advantage, but no specific FDA- or EMA-approved long-acting rFVIIa product was identified in the search results. Thus, this entry is based on the concept and expected properties for the long-acting formulation.

Other names
long-acting recombinant factor VIIalong-acting rFVIIalong-acting eptacog alfa (activated)
02

Targets

F9 (Coagulation Factor IX)F10 (Factor Xa)EPCR (Endothelial protein C receptor)Phospholipid bilayerPAR (Protease-activated receptors)F3 (Tissue factor)F7 (Coagulation Factor VII)

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